Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
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Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
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Despite the refutation of research articles by Piero Anversa, they continue to serve as a basis for funding requests from scientists who hope to prove that the heart can regenerate cardiac muscle.
Mark Cuban Cost Plus Drug Company now boasts over 700 prescription generic drugs for a variety of conditions, ranging from acid reflux to dementia to autoimmune diseases like Rheumatoid Arthritis.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
For years, PTC Therapeutics has attempted to win regulatory approval for its DMD drug, Translarna. Now, the company believes it has data that will support another filing for FDA approval.
The government of France launched its Healthcare Innovation 2030 strategy that aims to turn the country into a European innovation leader within the next eight years.
An FDA advisory committee voted against Acadia Pharmaceutical’s supplemental New Drug Application of Nuplazid tablets for the treatment of Alzheimer’s-related psychosis.
BMS, TG Therapeutics, Spero and Merck are all preparing for PDUFA dates over the next couple of weeks. Here’s a closer look.
The World Trade Organization approved vaccine patent waivers to increase the availability of COVID-19 vaccines to lower-income countries.
The vote came just over one week after the FTC announced it would probe claims regarding the role the middlemen play in determining retail prices of prescription drugs.
Checkpoint Therapeutics announced that its checkpoint inhibitor cosibelimab is showing positive objective response rate data in patients with locally advanced cutaneous squamous cell carcinoma.