FDA
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety, access and liability.
The FDA and NIH recently announced plans to phase out animal testing requirements for some therapies. While organoid and AI providers celebrate, scientists warn that questions over safety, applicability and implementation remain.
While the Trump administration has painted the jettisoning of staff and regulations as good for business, there are multiple reasons it’s unlikely to work out that way.
The FDA also approved the use of Zynyz as a monotherapy for patients with squamous cell carcinoma of the anal canal who are intolerant to platinum chemotherapy or whose disease has progressed.
As the FDA prepares for a busy Oncologic Drugs Advisory Committee meeting next week, an agency insider told BioSpace that volunteers with little training are scrambling to secure the required expertise after workforce cuts decimated the adcomm planning office.
The FDA also changed its tune and is now planning to convene an advisory committee to discuss Biohaven’s application.
AbbVie’s Emrelis is the first non-small cell lung cancer therapy approved for patients with high c-Met expression levels who have received prior lines of treatment.
President Donald Trump unwrapped a massive drug pricing policy as CMS prepares for the next round of Medicare drug price negotiations; Vinay Prasad to take the helm at the FDA’s Center for Biologics Evaluation and Research; Bayer cuts 2,000 more employees; Eli Lilly’s Zepbound scores again; and the Galapagos story turns again.
While industry groups decried the Trump administration’s new drug pricing order, analysts say it lacked details and the teeth to make a major impact without an act of Congress.
With President Donald Trump expected to deliver a drug pricing order on Monday that Big Pharma and patient groups alike have railed against, the industry’s tumultuous ride is far from over.
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