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AstraZeneca has secured the FDA’s green light for Voydeya, a first-in-class, oral, Factor D inhibitor developed as an add-on to its standard-of-care Ultomiris or Soliris for certain patients with paroxysmal nocturnal haemoglobinuria.
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Nearly 90% of senior leaders who were at the FDA a year ago are no longer with the agency, a BioSpace analysis shows. None remain from the Office of the Commissioner.
Early decisions about manufacturing and supply chains could prove costly as a company reaches the commercial stage.
While the TrumpRx deals only cover Lilly and Novo for now, the agreements are good for any cardiometabolic biotechs waiting in the wings, according to a new 2026 preview report from PitchBook.
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Biogen Inc. (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today provided an important update on the continuing progress of the Phase 4 post-marketing confirmatory study of ADUHELM ® (aducanumab-avwa) 100 mg/mL injection for intravenous use in Alzheimer’s disease.
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After covering the Alzheimer’s space through every high and low, BioSpace’s Annalee Armstrong welcomes back Roche for the 2026 Alzheimer’s Renaissance.
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Under a non-exclusive agreement, AstraZeneca is licensing biotech Revvity’s base editing technology to help create cell therapies for the treatment of cancer and immune-mediated diseases.
A three-judge panel is reviewing the legal challenge to the FDA’s approval of mifepristone. Any action by the court may result in further appeals, and possibly another Supreme Court decision.
An advisory committee of outside experts voted unanimously Thursday that Pfizer’s vaccine was effective in preventing severe disease, but some had questions regarding its safety.
More than $5 billion poured into the longevity space in 2022, and experts say the science is now primed to make a real difference in extending human healthspan.
In a 12-2 vote with two abstentions, the advisers said the benefits did not outweigh the risks.
The Phase III trial met its primary endpoint, a significant reduction of phenylalanine levels in the blood, with no severe adverse events reported, PTC Therapeutics reported Wednesday.
Fenebrutinib in a mid-phase trial reduced brain legions in relapsing forms of multiple sclerosis, the company reported. It is the only reversible BTK inhibitor currently in Phase III MS trials.
Athenex announced it will lay off 79 employees in Buffalo and 44 employees in Clarence as a result of the Chapter 11 filing.
The $75 million deal will leverage Scribe’s CRISPR technologies to develop gene therapies for neurological and neuromuscular disorders. Scribe previously struck deals with Biogen and Sanofi.
The Federal Trade Commission filed a lawsuit Tuesday seeking an injunction to prevent Amgen’s buyout of Horizon Therapeutics, which the agency says would “entrench monopoly drugs.”