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Biologics

BeiGene BLA Filed for Gastric Cancer

FDA accepts for review a BeiGene BLA for Tevimbra (tislelizumab) for combination use with chemotherapy in treating locally advanced unresectable or me...

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Human Drugs

Complete Response Issued on Minerva Schizophrenia Drug

FDA sends Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schi...

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FDA General

Ex-FDA Lawyer Temkin Joins Paul Hastings

Former FDA associate chief counsel and CDER policy advisor Eva A. Temkin joins Paul Hastings as chair of the firms FDA practice.

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Medical Devices

Vyaire Recalls Airlife Resuscitator

Vyaire Medical recalls its AirLife Adult Manual Resuscitator and oxygen reservoir bag due to out-of-specification components used in manufacturing.

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Human Drugs

Milestone Pharma Refiling Etrpamil NDA

After receiving a 12/2023 FDA refuse-to-file letter, Milestone Pharmaceuticals now says it will resubmit the NDA in the second quarter for etripamil n...

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Federal Register

Animal Drug Regs Amended to Reflect Approvals

Federal Register notice: FDA amends its animal drug regulations to reflect application-related actions animal drug applications approved during the fo...

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Human Drugs

Boehringer Reports Gains on Liver Disease Candidate

Boehringer Ingelheim reports data from its Phase 2 survodutide study showing that up to 83.0% of adults treated with the drug achieved a statistically...

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Biologics

After 2 Earlier Denials, Humira Biosimilar OKd

FDA approves Alvotech and Teva Pharmaceuticals Simlandi (adalimumab-ryvk) injection, an interchangeable biosimilar to AbbVies Humira.

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Federal Register

Rybrevants Regulatory Review Period Determined

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Janssen Biotechs Rybrevant (amivantamab-vmjw).

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Human Drugs

New App for Reporting Drug Amounts Produced

FDA creates a new CARES Act Amount Information Reporting application for drug establishments to use when submitting (xxx insert, delete xxx) annual re...