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Home » Keywords » adcom

Items Tagged with 'adcom'

ARTICLES

Woman holding display of business, regulatory icons

BIO CEO 2025: Navigating from policy to innovation to patients

Feb. 11, 2025
By Karen Carey
The fast pace in which the Trump administration has rolled out changes to how government and businesses operate – a disruptive effort that appears to be creating a new world order – has caught the attention of biopharma industry leaders who spoke Tuesday at the Biotechnology Innovation Organization’s CEO and Investor Conference in New York.
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New FDA adcom to consider Niemann-Pick drug at debut meeting

July 31, 2024
By Mari Serebrov
Zevra Therapeutics Inc. will make its case Aug. 2 for its Niemann-Pick type C (NPC) candidate, arimoclomol, when the U.S. FDA’s Genetic Metabolic Diseases Advisory Committee (GeMDAC) meets for the first time.
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US Worldmeds nabs FDA nod for oral maintenance therapy for high-risk neuroblastoma

Dec. 15, 2023
By Jennifer Boggs
Following the recommendation of its Oncology Drugs Advisory Committee, the U.S. FDA approved U.S. Worldmeds LLC’s eflornithine 192-mg tablets for use as a maintenance therapy in patients with high-risk neuroblastoma. Branded Iwilfin, the specific, irreversible inhibitor of ornithine decarboxylase previously known as DFMO, is expected to be available in the coming weeks.
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New FDA adcom to focus on genetic metabolic diseases

Dec. 13, 2023
The U.S. FDA is assembling a new advisory committee specifically focused on treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee, or GeMDAC, will be tasked with providing agency reviewers independent expert recommendations regarding regulatory applications as well as advice on scientific and policy issues.
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FDA icons

Is 20+ years too long for a confirmatory trial? ODAC to weigh in

Nov. 14, 2023
By Mari Serebrov
If everything goes according to the current plan, the U.S. FDA would get the final report of a confirmatory trial for Acrotech Biopharma Inc.’s Folotyn (pralatrexate) and Beleodaq (belinostat) in 2030 – more than two decades after Folotyn received accelerated approval to treat relapsed or refractory peripheral T-cell lymphoma and 16 years after Beleodaq was granted accelerated approval for the same indication.
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Sickle cell illustration

Adcom: Don’t sacrifice progress for perfection

Nov. 1, 2023
By Mari Serebrov
Had it been asked to, the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee would have voted Oct. 31 to recommend approval of Vertex Pharmaceutical Inc. and Crispr Therapeutics AG’s exagamglogene autotemcel, or exa-cel, as a one-time transformative treatment for severe sickle cell disease in individuals 12 and older.
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Sickle cell disease 3D illustration

No red flags flying ahead of adcom on Vertex’s SCD therapy

Oct. 27, 2023
By Lee Landenberger
It’s just a discussion next week of Vertex Pharmaceuticals Inc. and Crispr Therapeutics AG’s sickle cell disease (SCD) therapy, with no vote expected from the U.S. FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. The FDA isn’t questioning the drug’s efficacy as much as it is concerned about the effects of off-target editing.
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US senator: Time to turn rare disease passion into action with new pathway

Oct. 26, 2023
By Mari Serebrov
In a show of bipartisan solidarity, members of the U.S. Senate Special Committee on Aging voiced their support Oct. 26 for a new regulatory pathway to quicken access to new drugs for rare diseases that have no approved treatments.
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Clinical data illustration

Confirmatory trials job one with US accelerated approval

Oct. 11, 2023
By Mari Serebrov
As it continues its crackdown on accelerated approval, the FDA continues to stress that successfully completing confirmatory trials should be the top priority for sponsors of drugs that enter the U.S. market via accelerated approval.
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Xray showing lung cancer on tablet

Systemic polemic: ODAC panel BICRs over bias in Amgen’s Lumakras confirmatory trial, says no

Oct. 5, 2023
By Randy Osborne
The dark cloud of what the U.S. FDA called potential “systemic bias” rained on Amgen Inc.’s bid for full approval of Lumakras (sotorasib), a KRAS-G12C inhibitor that was granted accelerated approval in May 2021 for locally advanced or metastatic non-small-cell lung cancer after at least one systemic therapy.
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More Articles Tagged with 'adcom'

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