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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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Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
Following a Type A meeting with the regulator, the biotech says it has clarity about the next steps in demonstrating remestemcel-L’s effectiveness in acute graft-versus-host disease.
Bouncing back from two Complete Response Letters, Alvotech’s BLA for its Humira biosimilar AVT02 has been accepted by the regulator with a target action date of Feb. 24, 2024.
The company has dropped its gene therapy candidate TSHA-120 for giant axonal neuropathy after the FDA reiterated the need for a randomized, double-blind, placebo-controlled trial.
With 88% of life sciences organizations using or planning to use AI in recruitment and/or hiring, AI regulation is a priority for the industry.
Eli Lilly has filed lawsuits in several states seeking to prevent unauthorized selling of products that claim to contain tirzepatide, the active ingredient in its blockbuster type 2 diabetes drug Mounjaro.
Though it received backing from the Pulmonary-Allergy Drugs Advisory Committee in May, the FDA on Tuesday rejected ARS Pharmaceuticals’ neffy as a nasal spray for allergic reactions.
After facing regulatory roadblocks, Novartis is returning the anti-PD-1 antibody to the cancer-focused biotech, which regains global rights to develop, manufacture and commercialize tislelizumab.
The consent agreement struck between the FTC and Amgen and Horizon Therapeutics could have significant implications for ongoing and future M&A challenges, experts told BioSpace.
Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.