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FDA Approves Gileads Sunlenca for Some HIV Patients

[ Price : $8.95]

FDA approves Gileads Sunlenca, the first in a new class of drugs to treat some HIV-1 patients.

REMS Document Technical Conformance Guide

[ Price : $8.95]

FDA publishes a technical conformance guide for its guidance on the format and content of a REMS document.

Jet Medical, Other Companies, Pay $700,000 in Device Cases

[ Price : $8.95]

Jet Medical and two related companies agree to pay $700,000 to resolve criminal and civil charges involving Jets distribution of u...

Checkpoint Therapeutics BLA for Skin Cancer

[ Price : $8.95]

Checkpoint Therapeutics files a BLA for cosibelimab, an investigational anti-PD-L1 antibody for treating patients with metastatic ...

5 Observations on Glenmark FDA-483

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FDA releases the form FDA-483 issued following an inspection at the Goa, India-based Glenmark Pharmaceuticals drug manufacturing f...

FDA Approves Rozlytrek Companion Diagnostic

[ Price : $8.95]

FDA approves a Foundation Medicine blood-based companion diagnostic for Genentechs cancer drug Rozlytrek.

Group Urges Postponement of Alzheimers Drug Decision

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Public Citizen calls on FDA to postpone a 1/6-expected accelerated approval decision on a Biogen/Eisai Alzheimers drug until after...

Build Flexibility into Pubertal Development Guidance: BIO

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The Biotechnology Innovation Organization suggests modifications to an FDA draft guidance on measuring growth and evaluating puber...

AstraZeneca BLA for RSV Prevention in Infants

[ Price : $8.95]

FDA accepts for review an AstraZeneca BLA for nirsevimab for preventing respiratory syncytial virus lower respiratory tract diseas...

3 Federal Register Notices on New Device Classifications

[ Price : $8.95]

FDA publishes three Federal Register notices on device classifications related to de novo requests.