Vanda Pharmaceuticals Inc.: Vanda's Letter to FDA Commissioner Highlights Faulty Gastroparesis NDA Review
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As ...
STAT16h
Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
H1 Welcomes Former FDA Commissioner to Board of Directors, Acquires Ribbon Health, and Unveils 2025 Product Roadmap
H1 entered a definitive agreement to acquire Ribbon Health on December 12th, 2024. Backed by notable investors including General Catalyst, Andreessen Horowitz (a16z), BoxGroup, Rock Health, and Sachin ...
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Departing FDA Head Defends Agency’s Record, Looks Warily Ahead
Speaking with Stat ahead of his exit, Robert Califf expressed concern about the potential for brain drain in government. Other news is on promising drugs for lung cancer patients, the upcoming J.P.
Food & Beverage News1d
Karnataka merges dept of food safety with drug control, renames as FDA
It is now renamed as the Food Safety and Drug Administration (FDA) with immediate effect. The merged department will be headed by the Commissioner of Food Safety and Standards Department, who has been ...
White House readies nicotine proposal in administration’s final days
Click in for more news from The Hill{beacon} Health Care Health Care   The Big Story FDA rule to lower nicotine levels closes ...
Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
JD Supra1d
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
Biden admin working to effectively ban cigarettes in 11th hour proposal a 'gift' to cartels, expert says
A proposed FDA rule could effectively ban cigarettes currently on the market in favor of products with less nicotine. Cartels ...
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Trump’s FDA Transition Team Staffs Up As Commissioner Pick Awaits Approval
Meanwhile, newly installed Senate Majority Leader John Thune signals the president-elect's Cabinet nominees might not cruise to confirmation when hearings begin. Also, U.S. ethics director David ...
BioPharma Dive3d
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.