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A short-term funding measure to keep federal agencies, including the FDA, running at the start of the next fiscal year, which begins Oct 1, faces an uphill battle in the Senate. Read More
The FDA yesterday authorized booster shots of the Pfizer-BioNTech COVID-19 vaccine for people over 65 who have been vaccinated at least six months earlier with the two-dose shot. Read More
Incyte has received the FDA’s approval for its Opzelura (ruxolitinib) cream for treatment of mild-to-moderate atopic dermatitis, making it the first topical JAK inhibitor to receive the agency’s blessing. Read More
In the wake of the FDA’s controversial Aduhelm approval, public and private groups are calling on the agency to amend its accelerated approval pathway, including forcing companies to complete the required confirmatory studies in a timely manner and getting rid of drugs that fail the postmarket test. Read More
The FDA will create six supplement categories for biologics license applications (BLAs) based on submission content, with review goals of between three and 10 months. Read More
The new plant is projected to reduce time to drug commercialization, lower costs and enable more sustainable manufacturing processes, said the Anglo-Swedish drugmaker. Read More
The FDA is responding to frequently asked questions from generic drugmakers — including sponsors of drug-device combination products — on quality-related control correspondence with the agency in a draft guidance released yesterday. Read More
Nearly a dozen bipartisan lawmakers have sent a letter to the U.S. Patent and Trademark Office (PTO), arguing that it has enabled drugmakers to block competition by weakening a system Congress put in place for challenging patent abuses. Read More
The FDA’s drug approval decisions are made in a siloed, ad hoc manner, rather than using institutional knowledge of similar decisions that went before at the agency. And often, the judgments FDA officials make about the research before them on drug candidates are too subjective. Read More
Johnson & Johnson (J&J) is poised to be the next company to jockey for approval for its COVID-19 vaccine booster, just days after FDA’s vaccine experts voted no on Pfizer-BioNTech’s booster for the general population. Read More