Regulatory
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.
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.
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.
With widespread distribution of various vaccines against COVID-19 vaccine ongoing, companies are still refining their vaccines and therapies and generating new data. Here’s a look at two recent updates.
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