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182,012 Results for "fda".
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Psychedelics
FDA’s Lykos Rejection Delays—But Doesn’t Stop—Psychedelic Therapies
Psychedelic drug developers are undeterred by the FDA’s Complete Response Letter for the company’s MDMA therapy for PTSD, and experts expect Lykos will ultimately obtain approval.
August 19, 2024
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5 min read
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Heather McKenzie
Regulatory
FDA Action Alert: Travere, Avadel and Roche
The FDA has three regulatory milestones in the next two weeks, including a decision on a subcutaneous formulation of an effective multiple sclerosis therapy.
September 3, 2024
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3 min read
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Tristan Manalac
FDA
FDA Action Alert: BMS, Merck, Sanofi/Regeneron and More
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
September 16, 2024
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6 min read
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Tristan Manalac
Regulatory
AstraZeneca’s Imfinzi Scores Lung Cancer Wins With FDA’s NSCLC Approval, SCLC Priority Review
Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
August 16, 2024
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2 min read
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Tristan Manalac
People
Lykos CEO to Resign After FDA Rejection of MDMA Therapy, Layoffs
Amy Emerson is stepping down on the heels of the FDA last month rejecting Lykos Therapeutics’ MDMA-based therapy for post-traumatic stress disorder and the company laying off three-quarters of its staff.
September 6, 2024
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2 min read
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Tristan Manalac
Regulatory
FDA Action Alert: Ascendis, Gilead and Regeneron
In the next two weeks, the FDA will hand down its verdicts for three drug applications, including ones for multiple myeloma and hypoparathyroidism therapies.
August 12, 2024
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3 min read
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Tristan Manalac
Legal
Novartis Loses Court Case to Block Entresto Generics After FDA Denies Petition
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
August 13, 2024
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2 min read
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Tristan Manalac
Approvals
Servier Gets FDA Approval for First Targeted Therapy for Grade 2 IDH-Mutant Glioma
Servier Pharmaceuticals’ vorasidenib on Tuesday secured the FDA’s green light for the treatment of patients with grade 2 gliomas carrying mutations in the IDH gene.
August 7, 2024
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2 min read
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Tristan Manalac
Opinion
Congress Must Reauthorize FDA Program for Pediatric Rare Diseases
Why I advocated on Capitol Hill this month for the renewal of the FDA’s Priority Review Voucher program
July 15, 2024
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6 min read
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Matthew Winton
Policy
Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority
The U.S. Supreme Court on Friday overturned the long-standing Chevron doctrine, which required courts to defer to federal agencies and their interpretation of statutes, putting potential limits on the FDA’s regulatory decisions.
July 1, 2024
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2 min read
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Tristan Manalac
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