Regulatory
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.
Citing Russia’s agricultural regulatory agency, Reuters reported the new vaccine called Carnivac-Cov will be used against the virus in dogs, cats, foxes and mink.
Illumina plans to continue to pursue its acquisition of Grail Inc. despite the objection of the U.S. Federal Trade Commission.
AbbVie won the NDA on the strength of definitive results in a Phase III ADVANCE trial, where atogepant met all six secondary endpoints at the 30-60 mg dose range, proving statistically significant in heading off migraines in nearly 2500 adult participants who experience them between 4-14 days per month.
Merck is having a very busy week. Here’s today’s news.
The report listed four scenarios in order of likelihood, with the top being from bats through another animal.
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.
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