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The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations. Read More
Paxlovid is currently FDA-authorized for treatment of mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older weighing at least 40 kg. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee agreed yesterday — somewhat grudgingly — that Rebyota (RBX2660), Rebiotix’s standardized fecal microbiota suspension, is a safe and effective treatment for recurrent Clostridium difficile infections (CDI). Read More
In another move to address the opioid crisis, the FDA has issued a guidance — effective immediately — that clarifies some supply chain requirements for the overdose treatment Naloxone (naloxone hydrochloride) to help make the treatment more accessible. Read More
Spectrum Pharmaceutical’s experimental cancer drug Pozenveo (poziotinib) got the thumbs down from the FDA’s Oncologic Drugs Advisory Committee (ODAC) in a vote of nine to four yesterday. Read More
Reauthorization of FDA’s user fee legislation moved ahead a step on Thursday as leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee and the House Energy and Commerce Committee agreed to include a slimmed-down version of user fee legislation and smaller policy riders on a short-term government funding bill, or continuing resolution (CR). Read More
In briefing documents, the FDA expressed four major concerns about Pozenveo (poziotinib), Spectrum Pharmaceutical’s experimental lung and breast cancer drug, ahead of today’s meeting of the FDA’s Oncologic Drugs Advisory Committee. Read More
Makers of generics and biosimilars who have a hard time obtaining the samples of the reference product they need to develop their alternative products can turn to the FDA for documentation to present to reluctant brand-name owners. Read More