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Bird Flu Update: Mass layoffs hit U.S. Food and Drug Administration
03 Apr 2025 21:10 GMT
… positions with the U.S. Food and Drug Administration. In particular, those that dealt … administrative staff fired at the FDA’s Veterinary Laboratory Investigation and …
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T-Cell Acute Lymphoblastic Leukemia Clinical Trials And Studies 2025: EMA, PDMA, FDA Approvals, Mechanism Of Action, ROA, NDA, IND, And Companies
04 Apr 2025 04:11 GMT
… Designations from the U.S. Food and Drug Administration for the treatment of R …
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Dismantling the FDA’s Tobacco Office Marks a New Beginning
04 Apr 2025 04:28 GMT
… at the Food and Drug Administration (FDA) has finally arrived. The FDA’s Center … by scientific evidence. Internal FDA comments to the inquiry … and independent innovators. The FDA’s statutory mandate is … the illicit market.
The FDA must drop its ingrained …
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Level achieved: Orthocell gains FDA approval for flagship nerve repair product
04 Apr 2025 02:10 GMT
… US market, receiving US Food and Drug Administration (FDA) clearance for its flagship … $2.bn).
Remplir’s FDA approval is a landmark development … medicine companies to have an FDA approval,” Orthocell CEO and … Moore said the US-FDA clearance was a great …
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Novartis receives US FDA accelerated approval for Vanrafia, the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy
04 Apr 2025 03:33 GMT
… announced the US Food and Drug Administration (FDA) has granted accelerated … intended to support traditional FDA approval.
“Today’s … nephropathy with today’s FDA accelerated approval of Vanrafia … Fabhalta having been granted FDA approval in C3 glomerulopathy …
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Orthocell clears FDA regulatory hurdle and is primed to launch into the US with Remplir
04 Apr 2025 03:39 GMT
… the regulatory bar with the Food and Drug Administration (FDA), giving it the green light … to announce we have received FDA clearance for our market-leading …
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Cuts, ousters and drama at the FDA
04 Apr 2025 01:21 GMT
… ’s rough first week as FDA Commissioner. Biotech stocks tumble even … ’s biotech podcast.
STAT’s FDA reporter Lizzy Lawrence joins co … F. Kennedy Jr. forced top FDA officials to resign at a … time when newly sworn-in FDA Commissioner Makary is still figuring …
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FDA Grants Accelerated Approval to Vanrafia for IgAN, a Rare Kidney Disease
03 Apr 2025 23:42 GMT
The FDA has granted accelerated approval for … intended to support traditional FDA approval.
Related: FDA Approves Novartis’ Oral Fabhalta … kidney disease. Fabhalta was granted FDA approval in C3 glomerulopathy (C3G …
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This company has entered a trading halt, is it about to announce FDA approval?
03 Apr 2025 23:22 GMT
… .47. Why was it seeking FDA approval? Orthocell produces a range … the results of the US FDA 510(k) clearance application to … announce the outcome. If the FDA has granted 510(k) clearance … may need to address the FDA's concerns before proceeding …
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FDA approves Amgen's Uplizna in IgG4-related disease
03 Apr 2025 22:48 GMT