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The FDA has so far secured 600 new hires and is looking for 1,600 more as interim leadership at the agency aims to rebuild the workforce and morale after more than a year of intense attrition.
Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The company announced a $350 million public offering on Monday shortly after revealing positive Phase II results for its investigational congenital adrenal hyperplasia drug, with hopes to one day compete with Neurocrine’s Crenessity.
The cardiovascular biotech was also named as one of BioSpace’s top startups to watch on Wednesday.
Though specific data for bepirovirsen remain under wraps, GSK plans to file for approval in the first quarter of 2026.
Jazz’s Ziihera and BeOne’s Tevimbra plus chemotherapy led to what Truist Securities dubbed one of the strongest overall survival signals ever reported in a type of gastroesophageal cancer.
Cartography will hunt for novel tumor antigens, which Pfizer can opt into and advance into clinical development.
The acquisition is centered on Dark Blue Therapeutics’ small-molecule degrader of the MLLT1 and MLLT3 proteins, which is being tested for acute myeloid leukemia.
Novo Nordisk follows Christmas oral Wegovy approval with quick launch; Eli Lilly is headed for $94.3 billion in annual revenue by 2027, analysts predict; nine more pharmas strike Most Favored Nation deals but half remain unsigned; experts call for stability and rare disease action at FDA, and all eyes are on M&A ahead of the J.P. Morgan Healthcare conference next week.
After a prolonged funding chill, investors say 2026 is shaping up for continued dealmaking and diversified bets beyond oncology and immunology.
From biotech veterans to embattled modalities to a new wave of RNAi therapeutics, BioSpace’s NextGen Class of 2026 emerged during a tough fundraising environment in 2025. Check out the 15 battle-tested companies that caught our eye.
Recent breakthroughs and three decades of progress in treating Huntington’s disease