FDA

FDA has approved Foundayo, Eli Lilly's once-daily oral GLP-1 receptor agonist, as the first small molecule pill of its kind for obesity.

Kresladi becomes the first FDA-approved gene therapy for children with severe LAD-I due to biallelic variants in ITGB2, and Awiqli the first and only once-weekly basal insulin treatment for adults with type 2 diabetes.

FDA has granted accelerated approval to Avlayah, the first therapy engineered to cross the blood-brain barrier and treat the neurological manifestations of Hunter syndrome.

The warning letter is directed at promotional claims about Anktiva’s efficacy and use.

This is the agency's first approved treatment for acquired hypothalamic obesity.

FDA has approved Wegovy HD, a higher-dose 7.2 mg injectable semaglutide, based on Phase III data showing a mean weight loss of 20.7% in adults with obesity.

FDA has approved Icotyde as the first oral targeted therapy for moderate-to-severe plaque psoriasis, offering adults and adolescents a once-daily pill that blocks the IL-23 receptor.

Arexvy is now approved for adults aged 18 to 49 with underlying conditions that elevate their risk of severe RSV disease.

FDA cites systemic failures in how the company tracked and reported adverse drug events across several of its medicines, including semaglutide.

FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

FDA approved GSK's Wellcovorin as the first treatment for cerebral folate deficiency caused by a rare genetic variant.

The application is based on Phase III trial data showing the drug reduced the risk of invasive disease recurrence or death.

The drug is part of the Commissioner’s National Priority Review Voucher program.

FDA grants accelerated approval to Boehringer Ingelheim’s Hernexeos (zongertinib) for treatment-naïve HER2-mutant advanced NSCLC.

David Graziano, head of retail network at GoodRx, says the FDA’s crackdown on non-approved or “copycat” GLP-1 drugs could shift demand toward FDA-approved therapies while increasing the importance of affordable access through retail pharmacies.

FDA approves AstraZeneca’s fixed-duration, all-oral Calquence plus venetoclax regimen for first-line CLL and SLL in adults.

FDA is shifting its default standard for drug approvals, announcing that one adequate and well-controlled clinical trial will generally be sufficient for approvals.

Following a Type A meeting with the FDA’s Center for Biologics Evaluation and Research, Moderna’s flu vaccine candidate mRNA-1010 has been accepted for formal review after the company revised its regulatory strategy.

The new once-monthly dosing schedule for Rybrevant Faspro in combination with Lazcluze offers a more convenient option and also maintains efficacy and safety comparable to the prior bi-weekly regimen.

The letter follows Phase II data that did not sufficiently link biomarker reductions to clinical benefit.

The withdrawal is due to data shared from FDA reflecting that data included in the NDA submission is unlikely to meet the required threshold of evidence.

The approval of Keytruda (pembrolizumab) and Keytruda Qlex was supported by Phase III KEYNOTE-B96 data showing statistically significant improvements in progression-free and overall survival in patients with PD-L1–positive platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma.

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing partnerships to sustain momentum in its respiratory franchise.

The approval is for a new formulation of the medication that allows for it be provided as an oral film.

FDA’s complete response letter for subcutaneous Saphnelo highlights regulatory scrutiny around manufacturing and formulation changes in the industry.