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Hundreds of FDA Employees Get Termination Letters

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The Trump Administration fires hundreds of FDA probationary employees over the weekend as part of its efforts to trim government f...

Deciphera Pharma Gets OK for Romvimza

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FDA approves a Deciphera Pharmaceuticals NDA for Romvimza (vimseltinib) for treating adult patients with symptomatic tenosynovial ...

AlgoTx Will Continue ATX01 15% Development

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Based on partially successful Phase 2 study results, AlgoTx says it plans to continue developing ATX01 for chemotherapy-induced pe...

Gilead Seeks OK for Twice Yearly Lenacapavir

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FDA accepts for priority review a Gilead Sciences NDA for lenacapavir for twice-yearly use in preventing HIV as pre-exposure proph...

Suspend/Revoke all Covid mRNA Vaccines: Petition

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Citizens MAHA files a petition asking HHS and FDA to suspend and revoke EUAs and BLAs for mRNA Covid-19 vaccines and conduct a ful...

FDA Gladiator: Larry R. Pilot (1940-2025)

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Editor Jim Dickinson posts his obituary of Larry R. Pilot (84), who co-founded FDAs first medical device bureau and parlayed his i...

Gender Statement Added to Restored FDA Pages

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The Trump administration adds a gender ideology statement to two Web pages on draft guidances that FDA was ordered by a federal ju...

BMS Reports Disappointing Data in Melanoma Trial

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Bristol Myers Squibb says a Phase 3 trial evaluating Opdualag (nivolumab and relatlimab-rmbw) for treating patients with completel...

ICU Medical Recalls Potassium Chloride Lot

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ICU Medical recalls one lot of potassium chloride injection bags packaged in cases indicating 20 mEq per bag due to a mislabeling ...

New Endpoint Option for Alcohol Use Disorder

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CDER posts a drug development qualifying tool to support treatments for alcohol use disorder products.