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

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…

Novartis has received a request from the Department of Justice (DOJ) asking for information about the marketing and pricing of Entresto, the company’s blockbuster combination sacubitril/valsartan drug for heart failure.…

The FDA has teamed up with the National Institutes of Health (NIH), 10 pharmaceutical companies and five nonprofit organizations to launch the Bespoke Gene Therapy Consortium to accelerate development of…

A 10-day course of the inexpensive antidepressant fluvoaxamine cut the risk of COVID-19-related hospitalization by 32 percent in infected patients with comorbidities, a research team in Brazil has found. Source:…

President Biden has dropped all provisions aimed at lowering prescription drug prices from what is the scaled-down $1.75 trillion Build Back Better Act framework negotiated between the White House and…