FDA Rejects RP-1 in Melanoma: What the Deep Dive Will Unpack
The FDA has declined to approve RP-1 for melanoma. Medscape's data deep dive walks through what the agency's reasoning means for the melanoma drug pipeline and clinical practice.
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FDA
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FDA
FDA Accepts Allergan's sBLA for OnabotulinumtoxinA in Masseter Prominence
The FDA has accepted Allergan Aesthetics' sBLA for onabotulinumtoxinA to improve masseter muscle prominence, moving Botox toward…
FDA Issues Complete Response Letter for Galderma's RelabotulinumtoxinA
The US FDA has issued a Complete Response Letter to Galderma for relabotulinumtoxinA, halting the next-generation botulinum toxin…
FDA Advisers Back Replimune Skin Cancer Drug; Shares Surge
Replimune shares surged after FDA advisers backed the company's skin cancer drug, an oncolytic immunotherapy now awaiting a forma…
FDA Requests More Manufacturing Data on Fast-Onset Toxin TrenibotE
The FDA has requested additional manufacturing information on TrenibotE, the quick-acting botulinum toxin candidate, according to…
Acrotech Launches ADQUEY, Enters U.S. Dermatology Market
Acrotech has launched ADQUEY™, its new dermatology brand, marking the company's first entry into the U.S. dermatology market.
Nine Members of Congress Press Revlon Over FDA Talc Testing Failures
Nine members of Congress, led by Rep. Yvette Clarke, are demanding answers from Revlon CEO Michelle Peluso after an FDA warning l…
FDA Finds Data 'Insufficient' to Judge PFAS Safety in Cosmetics
FDA's MoCRA-mandated review of 25 PFAS covering 96% of intentional cosmetic use finds toxicology data incomplete; one PFAS flagge…
FDA Accepts BLA for Imsidolimab in Generalized Pustular Psoriasis
FDA accepts for review a BLA for imsidolimab, an IL-36–targeting monoclonal antibody, as a treatment for generalized pustular pso…
FDA Advisory Committee Backs Melanoma Therapy After Two Rejections
An advanced melanoma therapy that failed twice in prior reviews has won a favorable FDA advisory committee vote, reviving its pat…