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Following the FDA’s refusal to review Moderna’s investigational mRNA flu vaccine last week, Commissioner Marty Makary faced questions from the U.S. president about the agency’s handling of vaccines. It’s a clear signal that the tension long brewing at the drug regulator has now gone all the way to the top.
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The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is part of a larger communications crisis unfolding at the agency over the past nine months that has also ensnarled Sarepta, Capricor, uniQure and many more.
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Moderna’s combination vaccine candidate for COVID-19 and influenza outperformed licensed vaccines in older adults, according to late-stage results reported on Monday.
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While a prolonged, 15-day regimen of Paxlovid is safe, it appears to be ineffective at lowering the symptoms of long COVID, according to results of a Phase II trial funded by Pfizer and conducted by Stanford Medicine.
The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
Biomea Fusion’s early-stage investigational diabetes treatment BMF-291 has been slapped with a full FDA clinical hold on its Phase I/II trials due to concerns over liver toxicity.
Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.
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After rejecting a previous takeover offer from Future Pak, Vanda Pharmaceuticals is now fielding another acquisition proposal from Cycle Pharmaceuticals, which values the biotech at $8 per share.
AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.