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Oncology Guru Pazdur Named New CDER Director

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FDA names 26-year FDA veteran Richard Pazdur as the new CDER director, replacing George Tidmarsh after he recently stepped down am...

Avenzo Therapeutics Wins Fast Track for Lung Cancer Drug

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FDA grants Avenzo Therapeutics a fast track designation for AVZO-1418, the companys investigational EGFR/HER3 bispecific antibody-...

FDA Nixes Certain Boxed Warnings from Hormone Therapy

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FDA says it will begin removing broad boxed warnings from menopause-related hormone replacement therapy products based on a recent...

Roche BTK Inhibitor Sees Positive Phase 3 MS Data

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Roche says its investigational Brutons tyrosine kinase inhibitor fenebrutinib showed the strongest late-stage results yet reported...

FDA Flags Sterility, Cleaning and Quality at Alvotech Facility

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FDA cites Alvotechs Reykjavik, Iceland, manufacturing site for widespread sterility assurance, environmental monitoring, and quali...

Mercks Oral PCSK9 Candidate Cuts LDL by Up to 60%

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Merck reports positive Phase 3 results for its oral PCSK9 inhibitor enlicitide, showing LDL-cholesterol reductions approaching 60%...

Fresenius Recalls 4 Lots of Famotidine Injection

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Fresenius Kabi recalls three lots of its famotidine injection after reserve samples from one lot tested out of specification for e...

Experts Urge Federal Action on Supply Chain Resilience

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A group of leaders from government, academia, and the pharmaceutical industry call for sweeping federal action to stabilize the U....

Cogents Bezuclastinib Combo Delivers Phase 3 Win

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Cogent Biosciences reports positive data from a Phase 3 study of its KIT inhibitor bezuclastinib, saying that the drug combined wi...

FDA 483 Cites Quality Deficiencies at Indian Drug Plant

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FDA cites Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its q...