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The FDA sent a warning letter to Round Rock, Texas-based Davati Medical Supply instructing it to stop marketing an unapproved quadrivalent influenza vaccine. Read More
The World Health Organization (WHO) has recommended the use of interleukin-6 receptor blockers — including Roche’s Actemra (tocilizumab) and Sanofi’s Kevzara (sarilumab) — plus corticosteroids for the treatment of severe COVID-19. Read More
Colorado has become the second state — after Minnesota — to pass a law capping the price of insulin for both insured and uninsured diabetic patients, continuing a trend of states passing legislation to rein in the cost of the life-saving medicine — so far, mostly for people with health insurance — in response to what they see as inaction by Congress and the federal government. Read More
The FDA has mostly — but not entirely — rejected the Celgene/Bristol Myers Squibb (BMS) petition to delay generic versions of its blockbuster chemotherapy drug Abraxane (paclitaxel) from hitting the market. Read More
Another lawmaker has joined the ranks of those calling for a federal investigation into an allegedly improper collaboration between FDA officials and Biogen to ensure approval of Aduhelm (aducanumab), the first new Alzheimer’s treatment in nearly 20 years. Read More
She has held several prominent positions within the agency, including lead negotiator with industry for the FDA’s commitments under the Generic Drug User Fee Act (GDUFA) III. Read More
Teva Pharmaceuticals has filed federal lawsuits against Aurobindo and Lupin over their planned generics of its Huntington’s disease drug Austedo (deutetrabenazine). Read More
On its long slog toward FDA approval, teplizumab, a monoclonal antibody being developed for delaying or preventing type 1 diabetes, has stumbled over bioequivalency concerns. Read More
Emergent BioSolutions’ troubled Bayview, Md., plant, a manufacturing site for Johnson & Johnson’s COVID-19 vaccine, repeatedly failed to seal off a preparation area for vaccine ingredients and allowed production garbage to be carried through the area, leading to contamination, explains Peter Marks, director of FDA’s Center for Biologics Evaluation and Research in a memorandum about the plant’s operations. Read More
The FDA details its latest procedures for evaluating color additives or flavors added to a new oral drug in a new manual for the agency’s staff. Read More