Regulatory
The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.
Heading into the middle of January, companies announced plenty of new clinical trial news. Here’s a look.
Former Food and Drug Commissioner Robert Califf is one step closer to returning to his old office after the Senate Health, Education, Labor and Pensions Committee advanced his nomination.
Researchers from the Medical University of Bialystok in Poland identified a gene that appears to double the risk of severe COVID-19.
PCN-101 was recently awarded Investigational New Drug (IND) status by the U.S. Food and Drug Administration. It’s a for treating the patients with treatment resistant depression.
The Centers for Medicare and Medicaid Services indicated it would cover the cost of these drugs and any necessary scans — but only “if they are enrolled in qualifying clinical trials.”
The U.S. averages more than 700,000 new COVID-19 cases per day. As of Saturday, there were 4.91M cases, more cases in seven days than in April, May, June, and July 2021 combined.
Evidence continues to accumulate suggesting that Omicron, although significantly more infectious than previous COVID-19 strains, causes less severe disease.
Janssen Pharmaceutical has recently applied for Biologics License Application for its relapsed or refractory (r/r) multiple myeloma drug. Here’s all about it.
Reuters alleges Johnson & Johnson knew of the ketoacidosis risk of its diabetes drug Invokana but covered it up.
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