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Human Drugs

Keros Halts Some Dosing in Cibotercept Trial

Keros Therapeutics stops some dosing in a Phase 2 clinical trial of cibotercept (KER-012) in combination with background therapy in patients with pulm...

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Human Drugs

FDA Hasnt Inspected Factory with Recalls: ProPublica

A detailed ProPublica investigative report says FDA failed to inspect a Glenmark Pharmaceuticals facility in India that had multiple drug recalls in a...

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Human Drugs

Trump Unclear on Abortion Pills in Interview

In a Time interview, president-elect Donald Trump said it has always been his commitment to preserve access to abortion pills, but also said the issue...

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Human Drugs

Generics Seek Legislation to End Drug Sameness Delays

The Association for Accessible Medicines urges Congress to pass pending legislation to allow FDA to disclose sameness information about a brand drug t...

Human Drugs

FDA Launches RWE Evidence Innovation Center

FDA launches the CDER Center for Real-World Evidence Innovation with four areas of initial focus.

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Human Drugs

U.S. Approves More New Drugs than EU, Japan: Analysis

An IQVIA analysis of novel active substance approvals from 2014 to 2022 in the U.S., EU, and Japan shows the U.S. approves more new drugs and approves...

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Medical Devices

J&J Impella Heart Pumps Get Expanded Indications

FDA approves a Johnson & Johnson MedTech PMA supplement for expanded indications for the Impella 5.5 with SmartAssist and Impella CP with SmartAssist ...

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Human Drugs

Pfizer Reports Favorable Ibrance Breast Cancer Data

Pfizer says data from the Phase 3 PATINA trial demonstrated that adding Ibrance (palbociclib) to current standard-of-care first-line maintenance thera...

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Marketing

DTC Ad Enforcement to Increase Under Trump: Panel

Lawyers on a Food & Drug Law Institute enforcement panel warn that the incoming Trump administration is likely to target and seek increased enforcemen...

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Federal Register

FDA Revokes EUAs for B.Braun Covid Devices

Federal Register notice: FDA announces the revocation of B. Braun Medical emergency use authorizations for three Covid-related devices.