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US FDA grants breakthrough status to Dizal s sunvozertinib

Dizal Pharmaceutical has obtained breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for its sunvozertinib.

Form 10-K Jaguar Health, Inc For: Dec 31

Form 10-K Jaguar Health, Inc For: Dec 31
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Form 10-K Evofem Biosciences, Inc For: Dec 31

Form 10-K Evofem Biosciences, Inc For: Dec 31
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Citizen Petitions, Class Actions Call for FDA Action on Drug Products Containing Benzene | Morgan Lewis

Spurred by a March 5, 2024 citizen petition to the Food and Drug Administration (FDA), a flurry of class action complaints have been filed claiming that drug makers failed to warn.

Zydus Life gets tentative USFDA approval to market Letermovir tablets

In a press release, the pharmaceutical business stated that the USFDA has tentatively approved Zydus Lifesciences, together with its subsidiaries and affiliates, to manufacture and sell Edaravone Injection in a single-dose vial.

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