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As Daré Biosciences approaches a pivotal year with a key product launch ahead, the company kicked off an open public offering, providing a chance for individuals to get involved for as little as $250.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
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As Big Pharma companies consider foregoing European drug launches to avoid reducing drug prices in the U.S. in alignment with Trump’s Most Favored Nation policy, patients will suffer.
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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.
With Ascendis Pharma entering the achondroplasia space last month and BridgeBio on deck, BioMarin faces competition. Adding to the pressure, the company suffered a setback Monday when it halted two studies of Voxzogo in other growth-related conditions following multiple cases of hip injuries in other trials of the drug.
Structure Therapeutics’ oral obesity drug elicited a placebo-adjusted weight loss of 16.3% at 44 weeks in a Phase 2 trial. The biotech is planning to launch a late-stage program for the drug later this year.