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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
The FDA is not required to follow the recommendations of the committee, and had expressed its own doubts about the drug in its briefing documents. 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
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 judge explained that the court was ruling on the parties’ competing motions to exclude expert testimony under Rule 702 of the Delaware Rules of Evidence. 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
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
The 340B Drug Discount Program needs more regulation, oversight and transparency to combat abuse by bad actors, according to members of the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee. Read More
Inadequate personnel training, non-implementation of quality control procedures and scuttle fly larva found on employee clothing are among the litany of observations from an FDA Form 483 levied on Shanghai-based CARsgen Therapeutics. Read More
The FDA has released two draft guidances on how sponsors can prepare for bioresearch monitoring inspections (BIMO) in both their marketing applications as well as prior to and during the BIMO inspections themselves. Read More