FDA
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes.
FEATURED STORIES
The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Draft guidance, issued by the FDA last week, could remove ambiguity and uncertainty that may have so far limited uptake of new approach methodologies, experts told BioSpace, particularly emphasizing the agency’s recommendations around defining NAMs’ regulatory purpose.
The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
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AstraZeneca on Monday secured FDA approval for its blockbuster Imfinzi, in combination with chemotherapy, to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.
Ipsen and Genfit’s elafibranor will now be marketed as Iqirvo and is the first new medicine approved in nearly a decade for the treatment of the rare liver disease, according to the companies.
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks.
The FDA on Friday approved GSK’s application to use Arexvy to vaccinate adults aged 50 to 59 years who are at increased risk of developing severe respiratory syncytial virus.
Approved for patients with low- to intermediate-risk myelodysplastic syndromes, Geron’s Rytelo is the first telomerase inhibitor to hit the market and the company’s first approved drug after 34 years in business.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.
An FDA advisory committee on Tuesday overwhelmingly rejected Lykos Therapeutics’ investigational MDMA-assisted therapy for post-traumatic stress disorder due to safety concerns and how the company conducted its trials.
Tris Pharma on Wednesday secured the FDA’s green light for Onyda XR, the first liquid non-stimulant nighttime treatment for attention deficit hyperactivity disorder in pediatric patients.
In the next two weeks, the FDA is scheduled to decide on four drug applications and hold two highly anticipated advisory committee meetings.