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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 from the agency’s expert advisory panel earlier in the week. Read More
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. Read More
Under the deal, 105 low- and middle-income countries will gain access to the treatment, following authorization from the World Health Organization and/or national regulators. Read More
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 Vicineum for treatment of bladder cancer. Read More
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 soliciting public comment on its research proposal. Read More
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. Read More
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 congressional Democrats. Read More
Houston-based Empower Clinic Services, doing business as Empower Pharmacy, has been sent a lengthy warning letter from the FDA that listed multiple violations — the company’s second warning letter in six years. Read More