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188,915 Results for "fda".
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Regulatory
FDA Action Alert: Amgen, Aldeyra and Argenx
In the coming two weeks, the FDA is expected to announce three big decisions, including one for a dry eye disease therapy.
March 31, 2025
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3 min read
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Tristan Manalac
Podcasts
Sarepta’s Elevidys Death, FDA’s Vaccine Move, Weldon Whiplash, PDUFAs in Cardio
Sarepta will update Elevidys’ label after a patient died following treatment; the FDA issues flu vaccine recommendations without advisor input; Trump CDC nominee Dave Weldon pulled at last minute; and FDA decisions expected for Alnylam’s Amvuttra in ATTR-CM and Milestone’s etripamil in tachycardia.
March 19, 2025
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2 min read
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Heather McKenzie
Editorial
This Might Be a Moot Point but the FDA’s Priority Review Vouchers Need Transparency
While Congress is renewing the priority review voucher program for rare pediatric diseases, the FDA should be required to keep public records of the passes changing hands, too.
March 7, 2025
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3 min read
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Annalee Armstrong
Regulatory
FDA Action Alert: GSK, Alnylam, Sanofi and More
On the agenda for the FDA this month are two RNA-based treatments for rare diseases.
March 10, 2025
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7 min read
·
Tristan Manalac
Opinion
FDA Faces Challenging Decision on Biomarker-Based Label Restrictions
The FDA’s Oncologic Drugs Advisory Committee recently voted to narrow the label for checkpoint inhibitors Keytruda and Opdivo in stomach and esophageal cancers based on PD-L1 expression levels—but the high unmet need in these patient populations should also be considered.
March 10, 2025
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5 min read
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Harpreet Singh
FDA
FDA Job Cuts, Key Departures Bring ‘Revolving Door’ Debate Front and Center
With the recently announced layoffs of 3,500 FDA staffers and exits of branch directors Patrizia Cavazzoni and Peter Marks, there could be a wealth of talent available to biopharma companies. Does this pose an ethical quandary? It depends on who you ask.
April 2, 2025
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6 min read
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Heather McKenzie
Government
Senate Confirms Makary as FDA Chief as Trump’s Health Nominees Move Forward
Marty Makary earlier this month distanced himself from the recent shake-ups at the FDA, including the cancellation of its vaccines advisory committee meeting and the steep layoffs at the agency.
March 26, 2025
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2 min read
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Tristan Manalac
Duchenne muscular dystrophy
Safety Questions Loom in Duchenne as Dyne, Wave and Others Plan FDA Filings
Several companies will head to the FDA seeking approval of new Duchenne muscular dystrophy treatments next year but the death of a patient taking Sarepta’s Elevidys raises important safety questions.
March 27, 2025
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8 min read
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Heather McKenzie
COVID-19
FDA Shoots Down Invivyd’s Bid to Expand EUA for COVID-19 Antibody
Pemgarda has a standing emergency use authorization as a prophylaxis for immunocompromised patients, but FDA’s stringent requirements for antibody activity boxed out its potential use as a post-exposure treatment.
February 24, 2025
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1 min read
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Dan Samorodnitsky
Government
Anxious Industry Awaits Makary’s Hearing Amid Disruptions, Layoffs at FDA
The Senate hearing for FDA Commissioner nominee Marty Makary comes after President Trump’s NIH pick, Jay Bhattacharya, was grilled by the legislative body on Wednesday.
March 6, 2025
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2 min read
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Tristan Manalac
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