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.
FEATURED STORIES
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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Coherus BioSciences, Inc. announced the Company has entered into a licensing agreement with Innovent Biologics, Co., Ltd.,, a leading biopharmaceutical company headquartered in China, to commercialize Innovent’s biosimilar candidate to Avastin® in the United States and Canada.
The new coronavirus infection appears connected to a seafood market in Wuhan City in China, which has more a population of more than 11 million.
The CRL not only brings up the potential toxicities of the drug, but also raises questions about the drug’s efficacy.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
Pharming Group N.V. announced it has received European Medicines Agency approval of a Type II Variation for a new production facility for the Company’s lead product, RUCONEST®.
AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma.
January isn’t a particularly busy month for PDUFA dates for the U.S. Food and Drug Administration, with only two scheduled for the month. Here’s a look.
Collins, a former member of the Innate Immunotherapeutics Board of Directors, was indicted in 2018 and resigned his seat last year.
Posimir is a non-opioid being developed for post-surgical pain. It is designed to be injected into the surgical site, where it delivers bupivacaine for up to three days post-surgery.
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.