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Nearly two years after the FDA approved hearing aids to be sold OTC without involvement of a licensed professional, a Government Accountability Office (GAO) study found that barriers to treatment remain, and stakeholders believe prices are too high. Read More
Recalled products from Medtronic and Megadyne have been deemed Class I by the FDA — Medtronic for a potential software issue and Megadyne for the potential for burn injuries during surgery. Read More
Eli Lilly will make a case for its antiamyloid antibody donanemab on June 10, trying to reassure the Peripheral and Central Nervous System Advisory Committee that the drug is safe, despite the serious adverse events related to the deaths of five people during the drug’s pivotal phase 3 trial. Read More
Drug-induced liver disease observed in a phase 1/2 clinical trial of Biomea Fusion’s BMF-219 (covalent menin inhibitor) in type 1 and type 2 diabetes has resulted in the FDA requesting a full clinical hold. Read More
A Chinese drugmaker was storing sterile injectable drugs bound for the US market on corroded metal racks which themselves stood in pools of water dripping from black mold-covered condensation pipes, FDA investigators found during a 483 inspection. Read More
DexCom’s G7 prescription continuous glucose monitoring (CGM) system now connects directly to Apple Watch for users in the US, making it the first to offer real-time glucose readings so that users can leave their phone behind and still receive timely readings. Read More
CDER plans to refuse to approve a supplemental new drug application (sNDA) for Vanda Pharmaceuticals’ Hetlioz (tasimelteon), in the latest of a back and forth battle over the drug dating back to 2018. Read More
Generic sterile injectables — such as antibiotics, anesthetics and vaccinations — faced a 91 percent risk of being in short supply in 2023 and 58 percent of injectable drugs went into shortage in 2023, according to a report by the United States Pharmacopeia (USP). Read More
The Association for Accessible Medicines (AAM) Biosimilars Council’s recent white paper recommends the FDA streamline its regulation of biosimilar development to allow more affordable biologics products to the market more quickly across the globe. Read More
Two devicemakers in Mississauga, Ontario — Techlem Medical and Trexo Robotics Holdings — received recently released FDA Warning Letters with Techlem cited for quality issues and Trexo for marketing unapproved products. Read More
Members of the FDA’s Psychopharmacological Drugs Advisory Committee voted strongly against recommending MDMA, also known as “ecstasy,” as a potential treatment for post-traumatic stress disorder (PTSD) at their meeting on Tuesday. Read More