FDA

Replimune received a second FDA complete response letter for RP1 in advanced melanoma, raising questions about the viability of its oncolytic immunotherapy program.

Dismissing the role of independent, outside experts in FDA decision-making weakens the drug review process.

Since the start of President Trump's second term, the FDA, CDC, CDER, and CBER have collectively cycled through more than a dozen leadership changes.

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FDA issued draft guidance that would eliminate certain clinical pharmacokinetic studies from the biosimilar development process.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes FDA’s single-trial approval pathway may accelerate development, but manufacturers face heightened litigation risk, pricing uncertainty and safeguards.

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.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, discusses FDA’s removal of the two-trial requirement marking a significant policy shift and prompting sponsors to consolidate into a single robust pivotal study.

Ron Lanton, Senior Partner & Global Strategist, Lanton, Lanton & Sosa Law PLLC, notes shifting regulatory signals for Moderna’s mRNA flu vaccine review and raises broader questions about the stability of the approval pathway.

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.

Jay Bregman, CEO and co-founder of Andel discusses how FDA’s planned action against non-FDA-approved GLP-1 products could reshape competition in obesity and diabetes care.

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.