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CGMP Deviations at Tyche Industries

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FDA warns Indias Tyche Industries about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Publish Guidance on Robotic Mastectomy: Petition

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Harmed Americans for Reform in Medical Device Safety asks FDA to repost two safety communications and to analyze and post its find...

Top Five 2024 FDA Data Quality Issues

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A Med Device Online guest column lists and analyzes FDAs top five data quality citation issues in 2024.

GSKs Penmenvy Vaccine for Meningococcal Disease

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FDA approves a GSK BLA for Penmenvy (meningococcal Groups A, B, C, W, and Y vaccine) for preventing invasive meningococcal disease...

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...