Clinical News
Drug safety alerts, recalls, approvals and health updates from DRAP, the FDA and WHO
- Approval31 Oct 2026FDA
FDA Approves First Plasmid DNA-based Immunotherapy for Adult RRP
The U.S. Food and Drug Administration has granted accelerated approval for Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for the treatment of adults with recurrent respiratory papillomatosis, a rare condition caused by human papillomavirus.
Read more - Recall30 Oct 2026FDA Safety Alerts
Recall of HemosIL AcuStar HIT-IgG(PF4-H) Test Kits Due to False Negative Risk
Instrumentation Laboratories (Werfen) has issued an urgent removal for specific lots of the HemosIL AcuStar HIT-IgG(PF4-H) device due to a performance issue. The affected lots have been found to exhibit a negative bias, which can cause patient sample results to fall incorrectly below the assay cut-off and yield false negative readings.
Read more - Recall30 Oct 2026FDA Safety Alerts
Recall and Use Update for StatStrip Glucose Hospital Meter Gen 2.0
The US FDA issued a correction and recall notice regarding the StatStrip Glucose Hospital Meter System Gen 2.0 manufactured by Nova Biomedical. The issue involves a risk where scanning barcodes can cause prior information to remain on the screen, potentially leading to glucose results being assigned to the incorrect patient or quality control ID. Unrecognized errors can result in delayed or inappropriate clinical management, posing serious risks particularly to critically ill patients and infants.
Read more - Recall29 Oct 2026FDA Safety Alerts
Early Alert: Medline Brand Beds and Accessories Recall for Fire and Entrapment Risks
The US Food and Drug Administration issued an early alert regarding an urgent medical device field safety notice by Medline to remove, discontinue, and exit the market for all Medline Brand beds and associated pendants, accessories, replacement parts, and bed-containing order packages. The action is due to risks of electrical overheating, fire, electrical shock, burns, entrapment, and asphyxiation.
Read more - Recall27 Oct 2026FDA Safety Alerts
B. Braun Removes Streamline Bloodline Set for Dialog+ Due to Leak Risks
The US FDA has issued an early alert regarding a recall initiated by B. Braun for specific lots of the Streamline Bloodline Set for Dialog+. The recall was prompted because a required solvent application step during assembly was omitted, leading to inadequate bonding of the dialyzer connector.
Read more - Regulation22 Oct 2026FDA
FDA Launches Neuroscience Advancement and Innovation Nexus
The US Food and Drug Administration has announced the launch of the Neuroscience Advancement and Innovation Nexus, a new agency program aimed at accelerating medical product development for conditions affecting the brain and nervous system. The initiative brings together regulatory and scientific expertise across multiple agency centers to address complex challenges in neurology, psychiatry, substance use disorders, and pain management.
Read more - Recall21 Oct 2026FDA Safety Alerts
Wedgewood Pharmacy Recalls Compounded Veterinary Medications Over Potential Potency Inconsistencies
Wedgewood Pharmacy LLC has initiated a recall of certain compounded veterinary medications within expiry at the provider and customer level. The action was taken following internal quality findings of inconsistencies in analytical testing data generated by the company's laboratory, which could result in subpotent or superpotent products. The affected items were distributed throughout the United States between February 18, 2026, and October 6, 2026.
Read more - Approval21 Oct 2026FDA
FDA Approves Hibsago for Chronic Hepatitis B Treatment
The US Food and Drug Administration has approved Hibsago (bepirovirsen) injection to be used alongside existing antiviral therapy for treating specific adults with chronic hepatitis B virus infection who do not have cirrhosis. Hibsago functions as an antisense oligonucleotide designed to target genetic instructions used by the virus to replicate and produce viral proteins.
Read more - Approval20 Oct 2026FDA
FDA Approves First Generic Estradiol and Levonorgestrel Transdermal Patch
The US Food and Drug Administration has approved the first generic version of Climara Pro (estradiol and levonorgestrel transdermal system, 0.045 mg per day/0.015 mg), manufactured by Zydus Pharmaceuticals (USA) Inc. The patch is applied once weekly and is indicated for women with an intact uterus to manage moderate to severe vasomotor symptoms of menopause and to help prevent postmenopausal osteoporosis.
Read more - Regulation20 Oct 2026FDA
FDA Issues Final Guidance on Prescription Drug Apps and Software
The US Food and Drug Administration has released final guidance to establish a regulatory framework for how pharmaceutical companies develop, distribute, and label apps used with prescription medications.
Read more - Drug Safety20 Oct 2026FDA Safety Alerts
FDA Updates Import Alert for Certain Olympus Medical Devices from Japan
The US Food and Drug Administration (FDA) has updated its letter to health care providers regarding an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The agency took this action due to concerns related to ongoing Quality System regulation violations. The updated alert prevents specific models of ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, ingestible telemetric gastrointestinal capsule imaging systems, and enteroscopes from entering the United States.
Read more - Recall20 Oct 2026FDA Safety Alerts
FDA Issues Import Alert for Certain Olympus Medical Devices from Japan
The US Food and Drug Administration (FDA) has issued an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries. The action follows ongoing concerns regarding outstanding Quality System regulation violations. The affected devices include specific models of ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, ingestible telemetric gastrointestinal capsule imaging systems, and enteroscopes.
Read more - Recall20 Oct 2026FDA Safety Alerts
FDA Alerts on Cardinal Health Presource Kits with Recalled BD Alaris Pump Infusion Sets
The US FDA has released an Early Alert regarding Cardinal Health Presource convenience kits that contain BD Alaris Pump Infusion Sets affected by an ongoing BD recall. BD's updated testing demonstrated that certain infusion sets with restrictive components, such as check valves, filters, and microbore tubing, perform worse than previously specified. Significant deviations in infusion accuracy and delayed occlusion alarm times occur primarily at infusion rates under 1 mL/h and bolus volumes of 5 mL or less. These performance failures can lead to undetected under- or over-infusion, posing substantial risks of severe harm or death in high-risk patients such as neonates, pediatric patients, and critically ill individuals receiving critical infusions like antiarrhythmics or vasopressors. While no serious injuries or deaths had been reported as of August 19, 2026, the FDA is highlighting Cardinal Health's updated instructions. Healthcare providers are advised to review inventory, consult BD's performance disclosures, and transition to alternative syringe pumps when clinically indicated, while applying operational mitigations such as avoiding container heights over 21 inches above the pump and keeping pressure mode settings at or below 50 mmHg for rates below 10 mL/h.
Read more - Recall20 Oct 2026FDA Safety Alerts
FDA Alerts on Nova Biomedical StatStrip Gen 2.0 Glucose Meter Recall
The US Food and Drug Administration has issued a safety alert regarding a recall by Nova Biomedical for the StatStrip Glucose Hospital Meter System Gen 2.0. The manufacturer notified customers to remove affected devices or apply specific interim mitigation steps until a software update is available, as prior information may remain on the screen and lead to glucose results being assigned to the incorrect patient or quality control ID.
Read more - Recall20 Oct 2026FDA Safety Alerts
FDA Issues Alert on Cardinal Health Presource Kits Containing Recalled BD Alaris Infusion Sets
The US Food and Drug Administration has issued an early alert regarding a medical device correction initiated by Cardinal Health for its Presource convenience kits. These kits may include BD Alaris Pump Infusion Sets that are subject to a previously announced recall by BD and CareFusion.
Read more - Approval19 Oct 2026FDA
FDA Approves Jemperli for Certain Patients with Locally Advanced Rectal Cancer
The U.S. Food and Drug Administration has granted accelerated approval for a new indication for the immunotherapy Jemperli (dostarlimab-gxly). The approval covers the use of Jemperli alone in adults with previously untreated stage II or stage III locally advanced rectal cancer whose tumors are mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H).
Read more - Recall19 Oct 2026FDA Safety Alerts
FDA Classifies Philips Lumify Ultrasound Safety Notice as Class I Recall After Scanning Failures
The US FDA has classified a safety correction for Philips Lumify diagnostic ultrasound systems as a Class I recall, its most serious category. A software defect can cause the Android or iOS mobile application to fail to recognize a previously registered transducer, unexpectedly demanding re-registration before point-of-care scanning can proceed. Because re-registration requires access to a cellular network or Wi-Fi, scanning capability is blocked in environments lacking connectivity, such as ambulances, aircraft, and remote field settings. In addition, unstable physical USB cable connections between the transducer and mobile devices have caused sudden disconnections during use.
Read more - Recall15 Oct 2026FDA Safety Alerts
FDA Issues Early Alert for Edwards Lifesciences Commander M Delivery Systems Over Balloon Burst Risk
The US Food and Drug Administration (FDA) has issued an early alert regarding a critical safety issue involving specific lots of Commander M delivery systems, manufactured by Edwards Lifesciences. The devices are used to deliver SAPIEN M3 transcatheter mitral heart valves through blood vessels without open-chest surgery. Edwards Lifesciences has advised affected sites to immediately quarantine and remove the implicated lots from inventory.
Read more - Approval14 Oct 2026FDA
FDA Approves Expanded Use of Anktiva for BCG-Unresponsive Bladder Cancer
The U.S. Food and Drug Administration has expanded the approved indication for Anktiva, administered alongside Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that has not invaded the bladder muscle and has failed to respond to BCG treatment. This makes Anktiva the first FDA-approved therapy specifically indicated for this patient population.
Read more - Recall14 Oct 2026FDA Safety Alerts
Recall of Argatroban Injection Due to Particulate Matter
Par Health USA, LLC has announced a voluntary nationwide recall of twenty-two lots of Argatroban Injection to the hospital and user level. The recall was initiated following the detection of particulate matter identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel.
Read more - Recall14 Oct 2026FDA Safety Alerts
AVID Medical Recalls Convenience Kits Due to BD ChloraPrep Contamination
Avid Medical has issued a recall for specific convenience kits containing affected BD ChloraPrep applicators due to potential fungal contamination with Aspergillus penicillioides. The affected product is the IV Start Kit Non-Sterile, Kit, model number AVID KIT KRIV26-02, with kit lot number 1658437 and UDI 10809160460481. This supersedes previous instructions to over-label and discard only the component; customers are now advised to destroy the entire convenience kit.
Read more - Recall13 Oct 2026FDA Safety Alerts
FDA Alerts on Class I Recall of Medline Convenience Kits Due to Fungal Contamination
The US Food and Drug Administration has classified Medline's recall of select convenience kits as a Class I recall, its most serious category. The action affects kits containing specific lots of BD ChloraPrep applicators that face potential contamination with the fungus Aspergillus penicillioides under certain environmental conditions.
Read more - Recall10 Oct 2026FDA Safety Alerts
FDA Alerts on Class I Recall of CooperSurgical INCA Infant Nasal CPAP Sets
The US Food and Drug Administration has classified the recall of certain CooperSurgical INCA Infant Nasal CPAP sets as a Class I recall, the most serious category. The action affects specific lots of both the INCA Infant Nasal CPAP Complete Set and the Replacement Set used to provide continuous positive airway pressure to newborns and infants.
Read more - Drug Safety9 Oct 2026FDA Safety Alerts
Early Alert Issued for Philips Lumify Diagnostic Ultrasound System Issues
The US Food and Drug Administration has issued an early alert regarding a potentially high-risk device issue affecting the Philips Lumify diagnostic ultrasound system across multiple Android and iOS software versions. The problem involves a software glitch where the app may fail to recognize a registered transducer and demand unexpected re-registration, which requires a Wi-Fi or cellular signal. Additionally, unstable USB cable connections between the transducer and the compatible device can disrupt continuous functioning.
Read more - Recall9 Oct 2026FDA Safety Alerts
Par Health Recalls Two Lots of Brevital Sodium Due to Particulate Matter
Par Health has issued a voluntary recall to the hospital level for two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP). The action was initiated due to the presence of particulate matter identified as cellulose. Administration of the affected product carries a risk of life-threatening adverse health outcomes, including pulmonary emboli, blood vessel occlusions leading to tissue death and organ damage, and vein inflammation.
Read more - Recall6 Oct 2026FDA Safety Alerts
Nova Biomedical Issues Global Correction for StatStrip Glucose Hospital Meter
Nova Biomedical has initiated a global medical device correction for the StatStrip Glucose Hospital Meter System, specifically the Gen 2.0 model, due to a software issue. The defect can cause prior patient information to remain on the meter screen after scanning a patient ID barcode, potentially resulting in a glucose test result being assigned to the wrong patient's medical record.
Read more - Research5 Oct 2026FDA
FDA Seeks Public Input to Support Ibogaine Clinical Research
The U.S. Food and Drug Administration has issued a request for information detailing proposed approaches for the design of early-phase clinical trials involving ibogaine drug products. The agency is asking for public comments, data, and information on protocol elements such as dose selection, care settings, safety monitoring, and eligibility criteria.
Read more - Recall5 Oct 2026FDA Safety Alerts
Class I Recall Issued for BD Alaris Pump Infusion Sets Due to Performance Risks
BD and CareFusion have issued an updated Class I recall regarding certain BD Alaris Pump Infusion Sets compatible with the BD Alaris Pump Module model 8100. Testing revealed that certain sets with restrictive components perform significantly worse than previously disclosed, particularly at low infusion rates, which can lead to under- or over-infusion, delayed alarms, and bolus inaccuracies.
Read more - Recall5 Oct 2026FDA Safety Alerts
FDA Updates Alert on ICU Medical IV Tubing Sets Following Material Discoloration Inquiry
The US Food and Drug Administration has updated its communication regarding an IV tubing set correction initiated by ICU Medical. The affected products include Plum Administration Sets, IV Non-Dedicated Gravity Administration Sets, standard IV sets, and oncology sets equipped with drip chambers. The FDA has classified the issue as a Class II recall.
Read more - Recall2 Oct 2026FDA Safety Alerts
Class I Recall Issued for Draeger VentStar Resus Neo Breathing Circuits
The United States Food and Drug Administration has classified the removal of specific VentStar Resus Neo breathing circuits by Draeger as a Class I recall, denoting the most serious risk level. The action is due to the potential for obvious cracks to develop in the hose, which can cause the tubing to fall off or leak, leading to restricted ventilation, delayed therapy, desaturation, hypoxia, or patient death. Affected devices include model MP00310.
Read more - Approval2 Oct 2026FDA
FDA Approves First Size-Adjustable Pulmonary Valve for Children
The U.S. Food and Drug Administration has granted approval for the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve designed specifically for pediatric patients suffering from congenital pulmonary valve disease. The device is the first of its kind engineered to expand after initial implantation, allowing it to grow alongside the child and potentially reduce the necessity for multiple open-heart surgeries over time.
Read more - Recall1 Oct 2026FDA Safety Alerts
Greenwich Rx Recalls Compounded Glutathione Due to Endotoxin Risks
Greenwich Rx is voluntarily recalling specific lots of its compounded glutathione injection to the consumer level because of potential elevated endotoxin levels. The affected products are supplied as 200 mg/mL in 10mL multidose vials intended for subcutaneous injection and were distributed nationwide between June and September.
Read more - Drug Safety30 Sept 2026FDA
FDA Investigation Leads to Charges in Counterfeit Ozempic Scheme
The U.S. Department of Justice and the U.S. Attorney’s Office for the Middle District of Florida announced federal charges against two Indian nationals involved in a transnational counterfeit prescription drug distribution scheme. The investigation, assisted by the FDA's Office of Criminal Investigations, revealed that the defendants allegedly obtained counterfeit Ozempic from unauthorized sources in China and distributed it with fraudulent packaging and needles to U.S. distributors and pharmacies at deeply discounted prices.
Read more - Approval29 Sept 2026FDA
FDA Approves First Treatment for MCT8 Deficiency
The U.S. Food and Drug Administration has granted approval for Emcitate, containing tiratricol as tablets for oral suspension, to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome. This condition is a rare genetic disorder that causes excessive thyroid hormone levels in the blood while restricting it from entering the brain, leading to severe cardiovascular, metabolic, and developmental complications.
Read more - Recall25 Sept 2026FDA Safety Alerts
Boston Scientific Imager II Angiographic Catheters Recalled
Boston Scientific has issued a recall for Imager II Angiographic Catheters due to a manufacturing issue involving reduced levels of stabilizing agents in the catheter tips. This defect can lead to tip degradation and detachment, potentially causing procedural delays or life-threatening embolisms obstructing blood flow.
Read more - Recall24 Sept 2026FDA Safety Alerts
Recall of Automated Impella Controllers by Abiomed Due to Purge Failures
Abiomed has issued a recall, classified by the US FDA as the most serious type, for all global Automated Impella Controllers due to purge cassette recognition issues. These failures stem from problems with the purge flag component within the purge pressure sensor assembly, which can cause alarms such as Purge Disc Disconnected or Purge Disc not Detected. This can lead to prolonged delays in mechanical circulatory support, setup delays, or interruptions during ongoing support, and has been associated with serious injuries and deaths.
Read more - Recall24 Sept 2026FDA Safety Alerts
BD Issues Convenience Kit Correction for Trays with Recalled Ampules
The FDA has classified a device correction by Becton Dickinson for various convenience kits and procedure trays as a Class I recall. The affected products contain recalled sodium chloride ampules manufactured by Huons Co., Ltd. Compromised sterility of these components could potentially lead to serious adverse health events, including infections, sepsis, or organ dysfunction, particularly in vulnerable patients.
Read more - Drug Safety24 Sept 2026FDA
Federal Court Enters Consent Decree Against Gold Star Distribution Over Storage Conditions
A federal court has entered a consent decree of permanent injunction against a warehouse operator and its owner, stopping them from distributing FDA-regulated products including drugs, medical devices, food, and cosmetics. The action follows investigations by the FDA and state partners that revealed persistent insanitary conditions, including severe rodent and pest infestations.
Read more - Recall23 Sept 2026FDA Safety Alerts
FDA Early Alert Issued for Abiomed Impella Controllers
The US Food and Drug Administration has shared an early alert regarding an action by Abiomed to remove certain Automated Impella Controllers for hardware, firmware, and software updates. A retrospective review of servicing records identified potential quality issues that could impact device operation.
Read more - Drug Safety23 Sept 2026FDA Safety Alerts
Early Alert Issued for Ventilator Issue with React Health VOCSN Devices
The US Food and Drug Administration (FDA) has issued an early alert regarding a potentially high-risk device issue affecting all VOCSN ventilator devices with serial numbers 112786 and higher manufactured by Ventec Life Systems, doing business as React Health. The internal flow transducer cable connector in these devices may become unseated and lose communication with the internal flow transducer board, leading to device reboots and recurring System Fault 10 alarms.
Read more - Regulation21 Sept 2026FDA
FDA Updates Regulations to Advance Alternatives to Animal Testing
The U.S. Food and Drug Administration issued a direct final rule updating its regulations to clarify that appropriate non-animal methods may be used to test the safety of human drugs and biological products prior to human trials. This update incorporates scientific advancements such as human cells, organs-on-chips, and computer models, providing drug developers greater flexibility in choosing testing approaches.
Read more - Recall21 Sept 2026FDA Safety Alerts
Voluntary Recall of 0.9% Sodium Chloride Injection Due to Product Mix-Up
Otsuka ICU Medical LLC has issued a voluntary nationwide recall for one lot of 0.9% Sodium Chloride Injection, USP, 100mL single pack down to the user level. The recall was initiated because the affected sodium chloride overwrap may actually contain Potassium Chloride Injection 10 mEq.
Read more - Recall21 Sept 2026FDA Safety Alerts
Par Health Recalls Two Lots of Dexmedetomidine HCl Injection
Par Health has issued a voluntary recall to the hospital level for two lots of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection (400 mcg/100 mL). The action was initiated due to the discovery of particulate matter identified as cellulose or stopper material within the solution.
Read more - Recall21 Sept 2026FDA Safety Alerts
FDA Alerts on Correction of AVID Medical Convenience Kits Containing Recalled Saline Ampules
The US FDA has classified a product correction initiated by AVID Medical as a Class I recall, its most serious category. The action affects specific lots of procedural convenience kits, including continuous nerve block trays, single shot epidural trays, and basic or custom biopsy trays. These convenience kits contain 10 mL ampules of 0.9% sodium chloride injection manufactured by Huons Co., Ltd., which were subject to recall due to concerns regarding sterility assurance and product quality.
Read more - Recall18 Sept 2026FDA Safety Alerts
Sodium Chloride Flush Recall Issued by Spectra Medical Devices
Spectra Medical Devices has issued a recall for specific lots of Sodium Chloride Injection 0.9%, USP 10mL flush ampules manufactured by Huons Co., Ltd. The action follows an FDA manufacturing facility inspection that identified quality issues which could potentially compromise product sterility.
Read more - Recall18 Sept 2026FDA Safety Alerts
NOxBOXi Nitric Oxide Delivery System Corrected Due to Oxygen Leaks
The US FDA has issued a device recall notice regarding the NOxBOXi Nitric Oxide Delivery System with the NOxMixer module due to reports of oxygen leaks. These leaks stem from issues with the internal oxygen tubing or tubing connection within the NOxMixer module, which can cause therapy interruption or increased nitric oxide dosage. Affected units do not need to be removed from service immediately unless they fail pre-use checks, as the manufacturer is providing updated instructions and arranging hardware repairs.
Read more - Approval17 Sept 2026FDA
FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
The U.S. Food and Drug Administration has granted approval for Fayuvi (rebisufligene etisparvovec-hopf) as the first treatment for pediatric patients with mucopolysaccharidosis type IIIA, also known as Sanfilippo syndrome type A. The condition is a rare inherited disorder that causes progressive damage to the brain and nervous system, leading to a loss of developmental abilities over time.
Read more - Regulation17 Sept 2026DRAP
DRAP Publishes Guidance on Registration Pathways for Pharmaceutical and Biological Drugs
The Drug Regulatory Authority of Pakistan (DRAP) has released a guidance document describing the registration pathways available for pharmaceutical and biological drugs for human use.
Read more - Regulation15 Sept 2026FDA
FDA Opens Applications for Expedited IND Pilot to Speed Up First-in-Human Trials
The US FDA has finalised the design of its Expedited Investigational New Drug (IND) Pilot and is accepting applications until 30 October 2026.
Read more - Recall15 Sept 2026FDA Safety Alerts
Class I Recall: Medtronic Bravo CF Esophageal pH Capsule Delivery Devices
The US FDA has classed the recall of certain Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule delivery devices as the most serious type of recall. The devices are being removed from where they are used or sold.
Read more - Recall13 Sept 2026FDA Safety Alerts
Compounded Glutathione, Myer's Cocktail and Tri-Immune Boost Injections Recalled Over High Endotoxin
Centric Compounding, a US compounding pharmacy in Houston, Texas, is recalling six lots of injectable Glutathione 200 mg/mL, Myer's Cocktail and Tri-Immune Boost in 30 mL multidose vials. The glutathione raw material used to make them contained high levels of endotoxin.
Read more - Regulation11 Sept 2026DRAP
DRAP Invites Comments on Draft Amendments to the Drugs (Research) Rules, 1978
DRAP has published proposed amendments to the Drugs (Research) Rules, 1978, the rules that govern clinical research on medicines in Pakistan, and has asked stakeholders for their views.
Read more - Recall10 Sept 2026FDA Safety Alerts
Class I Correction for Medical Action Industries Epidural Kits Containing Recalled Ampules
The US FDA has classed a correction of certain Medical Action Industries epidural kits as the most serious type of recall. The kits contain Spectra Medical Devices ampules affected by an earlier recall from the manufacturer Huons Co., Ltd.
Read more - Regulation8 Sept 2026DRAP
DRAP Releases Revised Post-Registration Variation Guidelines (Revision 3)
DRAP has published revision 3 of its Post-Registration Variation (PRV) Guidelines for pharmaceutical and biological products.
Read more - Recall8 Sept 2026FDA Safety Alerts
Class I Recall: BMC Luna G3 APAP Devices Can Shut Down Because of a Firmware Defect
BMC Medical has reported a Class I recall of Luna G3 APAP sleep apnoea devices (model LG3600) running firmware version G3-2.00.76. Under a combination of high pressure, high breathing rate and high peak flow, the device shows an error and shuts down, which stops therapy.
Read more - Regulation7 Sept 2026DRAP
DRAP Requires 2-D Barcodes and Serialization on Imported Finished Pharmaceutical Products
DRAP has issued a notification on mandatory compliance with 2-D barcode and serialization requirements for imported finished pharmaceutical products. A corrigendum to the notification was released on the same day, 7 September 2026.
Read more - Public Health5 Sept 2026FDA
FDA Acts to Prevent Shortage of Neonatal Starter Parenteral Nutrition
The US FDA has issued an immediately effective guidance to prevent a supply gap in starter parenteral nutrition for premature and critically ill newborns. The risk arose after two outsourcing facilities that made standardised neonatal starter PN announced they were closing permanently.
Read more - Approval5 Sept 2026FDA
FDA Grants Accelerated Approval to Camizestrant for ESR1-Mutated Advanced Breast Cancer
The US FDA has granted accelerated approval to Etcamah (camizestrant) for adults with HR-positive, HER2-negative, locally advanced or metastatic breast cancer. It is approved in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib or ribociclib) for patients in whom an ESR1 mutation is detected, using an FDA-authorised test, during treatment with an aromatase inhibitor plus a CDK4/6 inhibitor.
Read more - Approval4 Sept 2026FDA
FDA Approves Zilganersen, the First Treatment for Alexander Disease
The US FDA has approved Zanvastro (zilganersen) injection for children and adults with Alexander disease, a rare, progressive neurological disorder caused by mutations in the GFAP gene. It is the first approved treatment for the disease.
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Summarised automatically from the official announcement. For educational purposes only — check the original source before making clinical decisions.