Due in part to a high number of adverse events and recalls associated with contaminated products, the FDA has issued a 21-page draft guidance to help manufacturers control microbiological contamination…
The FDA has released its commitment letter for the reauthorization of the Generic Drug User Fee Act (GDUFA), hammered out over several meetings with industry this year. Source: Drug Industry…
The FDA is slated to receive a one-time infusion of $300 million to upgrade its physical and technological infrastructure, according to the updated text of the proposed $1.75 trillion Build…
The FDA details how drugmakers should submit reports on the number of drugs they have distributed in a final guidance released Friday. Source: Drug Industry Daily
Since President Biden abandoned any provisions seeking to reduce prescription drug prices in the approximately $1.75 trillion Build Back Better bill framework unveiled last week, Democratic lawmakers have been trying…
Cortexyme isn’t letting a missed primary endpoint stifle its conviction that P. gingivalis, the bacteria that causes periodontal disease, is a root cause of Alzheimer’s disease (AD) and that its…
The FDA on Friday granted an updated Emergency Use Authorization (EUA) for the Pfizer/BioNTech COVID-19 vaccine for use in children ages five to 11 years — following a thumbs up…
Sesen Bio received an FDA warning letter Oct. 27, knocking the company over a 4-year-old personnel issue that came to light in a recent biologics license application (BLA) review of…
Takeda Pharmaceuticals is expanding its off-the-shelf CAR-T cell program yet again, with the acquisition of GammaDelta Therapeutics, a company researching the unique abilities of gamma delta T-lymphocytes to attack blood…
The FDA’s Office of Prescription Drug Promotion (OPDP) is aiming to understand how “targeted” mechanism of action (MoA) advertising affects how healthcare workers and consumers view a drug and is…