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Fallout from the resignation of FDA Commissioner Marty Makary continues as several other senior regulators are removed from their posts; pharma’s top paid CEOs make up to 358 times more than their employees; Revolution Medicine’s pancreatic cancer results highlight movement in the deadly disease space; more.
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Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
Nusano will bring a massive new radioisotope facility in Salt Lake City online by the end of the year, establishing a supply of starting materials for the next generation of radiopharmaceuticals.
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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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Alongside R1 Therapeutics, Mestag Therapeutics and iDEL Therapeutics also brought in money on Tuesday, helping to push their respective cancer portfolios forward.
While Johnson & Johnson retains the top revenue rank across the major pharma companies, Eli Lilly last year established itself as the clear leader in the obesity market, in the process capturing investors’ attention and enthusiasm.
The major pharmas are loaded up with trillions in firepower—but are sticking to mid-cap deals. One expert says it might be time to think outside the box and shake up the industry with some consolidation.
In its complete response letter, the FDA said Aldeyra had failed to demonstrate reproxalap’s efficacy in adequate and well-controlled studies. The FDA previously turned the candidate away in November 2023 and April 2025.
Although FDA Commissioner Marty Makary promised “an exciting treatment” for autism, what the agency delivered was a label expansion for leucovorin to treat the ultrarare cerebral folate deficiency. The regulatory process, which relied on a literature review rather than new evidence, stands in contrast to recent rare disease rejections in which the FDA cited a need for more rigorous evidence.
Pfizer has a lofty goal for the CDK4 inhibitor atirmociclib, the New York pharma’s answer to Ibrance’s loss of patent protection next year. In 2025, Ibrance led Pfizer’s oncology portfolio with $1.04 billion in sales.
The Phase 3 EMANATE study is a basket trial looking at the efficacy of Rhythm Pharmaceuticals’ injectable obesity drug across four types of obesities driven by specific genetic mutations.
Astellas Pharma and CytomX Therapeutics first partnered up in March 2020. For $80 million upfront, the Japanese pharma gained access to the biotech’s Probody platform to generate masked antibody therapies for cancer.
A Massachusetts judge called Kennedy’s efforts to reform the CDC’s vaccines advisory panel a “procedural failure,” adding that the new committee members do not “comport with governing law.”
In a highly competitive space, AI platforms must now prove themselves through proprietary data, focused pipelines and clinical readouts in competitive diseases. Promises of faster, cheaper drug discovery are not enough to entice strong investor engagement.