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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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While venture capital funding dipped to a six-year low in 2025, it nevertheless remained above pre-pandemic levels for Massachusetts-based biopharma companies, according to MassBio.
The deals will help Lilly diversify its portfolio that is heavily weighted on the obesity juggernaut tirzepatide, marketed as Mounjaro for diabetes and Zepbound for weight loss.
In 2025, made or projected biopharma workforce cuts affected about 42,700 employees, according to BioSpace tallies. BioSpace takes a deep dive into which companies and locations were impacted and speaks to experts about what to expect ahead—and why.
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.