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189,375 Results for "fda".
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FDA
FDA’s User Fee Negotiation Teams Gutted by Layoffs: Reuters
Losing the FDA’s senior negotiators would slow the renewal of the user fee programs “considerably,” according to policy and regulatory expert Steven Grossman.
April 18, 2025
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2 min read
·
Tristan Manalac
Podcast
Tariff Turmoil, FDA’s Future, Pfizer’s Obesity Setback and CEO Salaries Revealed
Donald Trump takes biopharma on a tariff-themed rollercoaster ride; J&J kicks off the Q1 earnings season; experts express concern about the FDA’s future; Pfizer’s obesity setback could be Viking’s gain; and BioSpace reveals the highest paid pharma CEOs.
April 16, 2025
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1 min read
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Heather McKenzie
Legal
Vanda Sues FDA Again, This Time Over Off-Label Use of Hetlioz for Jet Lag
Vanda is criticizing the FDA’s restrictions on information companies can provide regarding off-label use of approved medicines.
April 14, 2025
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2 min read
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Tristan Manalac
FDA
FDA Action Alert: Regeneron, Sanofi and Abeona
Lined up for the FDA in the coming weeks are a cell-based gene therapy for a rare skin disease and two product expansions for Regeneron, one with partner Sanofi.
April 14, 2025
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3 min read
·
Tristan Manalac
Government
HHS Secretary Kennedy Accuses FDA Employees of Being Industry ‘Sock Puppet’
Leerink analysts warned that Kennedy’s remarks to FDA staff would likely be a negative for the biotech industry.
April 14, 2025
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2 min read
·
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
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
·
Tristan Manalac
Regulatory
Former FDA Officials Sound Alarm: Visible Changes May Be ‘Tip of the Iceberg’
In the wake of unprecedented workforce cuts at the FDA, former Commissioner Scott Gottlieb and an unnamed former CBER director spoke to analysts about potential implications for drug review timelines and agency morale.
April 16, 2025
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3 min read
·
Heather McKenzie
Regulatory
Biotech Leaders Implore Sen. Cassidy To Step Up in Wake of FDA Cuts
Biotech companies are already seeing regulatory delays and plenty of uncertainty after around 3,500 FDA employees were cut by the Trump administration.
April 10, 2025
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3 min read
·
Annalee Armstrong
FDA
FDA After the Storm: Drug Review Delays and Increased Executive Oversight Expected
After the gutting of the Department of Health and Human Services, fears mount about the future direction of the FDA—with regulatory experts predicting delays in drug approvals and greater influence of political appointees.
April 14, 2025
·
6 min read
·
Heather McKenzie
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