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Bayer Files Nubeqa sNDA for Prostate Cancer

[ Price : $8.95]

Bayer submits a supplemental NDA for oral androgen receptor inhibitor Nubeqa (darolutamide), seeking approval for its use in combi...

ODAC Nixes Checkpoint Inhibitors in Gastric Cancers

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The FDA Oncology Drugs Advisory Committee votes not to recommend using immune checkpoint inhibitors in first-line advanced gastric...

AbbVie Parkinsons Trial Meets Endpoints

[ Price : $8.95]

AbbVie says a pivotal Phase 3 (TEMPO-1) trial for tavapadon in early Parkinsons disease met its primary and secondary endpoints.

FDA Proposal to Reclassify HBV Assays

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Federal Register notice: FDA proposes to reclassify qualitative hepatitis B virus (HBV) antigen assays, qualitative and quantitati...

Workshop on Live Biotherapeutics for Enterocolitis

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Federal Register notice: FDA, CDC, and NIH announce an 11/25 public workshop entitled Live Biotherapeutic Products to Prevent Necr...

More Support for Treating All Biologics the Same

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Two drug trade associations support an FDA approach to postapproval manufacturing changes in biosimilar and interchangeable biosim...

FDA OKs AZs Tagrisso Lung Cancer Drug

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FDA approves AstraZenecas Tagrisso for some non-small cell lung cancers.

Info Collection on Device Recall Authority

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Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Device Recall Authority.

Merck Favezelimab/Keytruda Trial Misses Endpoint

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Merck says a trial assessing favezelimab and Keytruda (pembrolizumab) failed to meet its primary endpoint in patients with previou...

FDA Posts 2 FDA-483s

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FDA posts forms FDA-483 issued following inspections at Samsung Bioepis in Incheon, Republic of Korea, and Terumo Yamaguchi in Yam...