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Panel to Mull Multi-Cancer Detection Tests

[ Price : $8.95]

Federal Register notice: FDA announces an 11/29 advisory committee meeting to discuss multi-cancer detection IVDs.

Consent Decree Against Drug Distributor

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The Puerto Rico federal court enters a consent decree requiring Droguera Betances, one of the territorys largest pharmaceutical di...

Covid Broke Vaccine Reporting System: BMJ

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A BMJ investigation raises concerns that the federal governments vaccine adverse event system is not operating as planned and safe...

FDA OKs Chikungunya Vaccine

[ Price : $8.95]

FDA approves a Valneva Austria BLA for Ixchiq, a vaccine for preventing chikungunya in individuals aged 18 years and above who are...

BMS Files sBLA for Breyanzi Expanded Use

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FDA accepts for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its curr...

FDA De Novo for Owlet Dream Sock

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FDA grants Owlet a de novo marketing authorization for its Dream Sock, an over-the-counter medical pulse oximetry solution for inf...

Samsung Seeks Interchangeable Humira Biosimilar

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FDA accepts for review a Samsung Bioepis supplemental BLA that seeks an interchangeability designation for its Hadlima (adalimumab...

Brochure Overstates Phexxi Benefits: OPDP

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An FDA untitled letter cautions Evofem Biosciences that a promotional brochure for its on-demand contraceptive Phexxi overstates t...

Takeda Gets Approval for Fruzaqla

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FDA approves a Takeda Pharmaceuticals NDA for Fruzaqla (fruquintinib) for use in certain adult patients suffering from metastatic ...

FDA Updates Keytruda Gastric Cancer Indication

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FDA revises the indication for Mercks Keytruda and approves a companion diagnostic test.