Food and Drug Administration (FDA)
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Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee published their objections to the drug in a JAMA article.
The U.S. Food and Drug Administration approved two new treatments for multiple myeloma and pulmonary hypertension.
Merck is having a very busy week. Here’s today’s news.
The FDA-approved ide-cel, which will be marketed under the brand name Abecma is going to be the second therapy for myeloma. Here’s everything you need to know.
The Orphan Drug Act passed in 1983 and granted tax credits, subsidies and fee waivers for rare disease drug development in areas of unmet need. It also guaranteed seven years of market exclusivity following approval, longer than the five years typical for most new chemical entities.
As this week’s FDA Action Alert emphasizes, not everything goes as planned with the U.S. FDA. With three PDUFA dates, two of them ran into issues. Read on to find out more.
There appears to be some evidence that the agency is cracking down in general, although there’s debate among analysts about what exactly is going on.
Three days after U.S. Food and Drug Administration staff raised safety concerns over Pfizer’s and Eli Lilly’s NGF osteoarthritis drug tanezumab, an advisory panel has also posted its own objections.
Keytruda (pembrolizumab) won another regulatory victory, making it the first checkpoint inhibitor approved by the U.S. FDA for first line treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction carcinomas regardless of PD-L1 expression.
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