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189,852 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
·
Heather McKenzie
FDA
FDA Alumni, Experts Call on Makary To Stand Up Against Agency’s Politicization
In a recent interview, FDA Commissioner Marty Makary said there “should be nothing political about the FDA.” Recent actions taken by HHS Secretary Robert F. Kennedy, Jr. and others within the department appear to be at odds with this sentiment.
April 29, 2025
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6 min read
·
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
·
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
Regulatory
Vanda Escalates Vendetta Against FDA, Blasts ‘Bureaucrats’ for Delaying Stomach Drug
The tradipitant saga stretches back to September 2024, when the FDA declined to approve Vanda’s drug in gastroparesis, a stomach condition characterized by delayed gastric emptying.
April 24, 2025
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2 min read
·
Tristan Manalac
FDA
Fact or Fiction? Unpacking FDA Commissioner Marty Makary’s First Interviews
As Marty Makary nears the end of his first month on the job, the FDA Commissioner sat down for two interviews, offering statements that alternatively contradict and jibe with reported events.
April 25, 2025
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7 min read
·
Heather McKenzie
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
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
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
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