FDA Related News

Human Drugs

GSK Long-Acting Biologic Approved for Asthma

FDA approves GSKs Exdensur (depemokimab-ulaa), an ultra-long-acting biologic for severe asthma.

Human Drugs

FDA Denies Akebia Reconsideration Petition

FDA denies an Akebia Therapeutics 2019 petition for reconsideration seeking five-year new chemical entity exclusivity for its Auryxia.

Human Drugs

FDA Easing Drug Approval Standards: Column

A Medshadow column raises concerns about FDAs stated efforts to allow some drugs to be approved based on a single pivotal trial.

FDA General

Republicans Dismiss RFK Jr. Subpoena Vote for Testimony

House Energy and Commerce Committee Republicans blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congres...

Biologics

Sen. Johnson Seeks FDA Docs on Covid Vaccine Deaths

Sen. Ron Johnson (R-WI) demands that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 1...

Medical Devices

Medical Device RWE Guidance

FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evidence for regulatory...

Human Drugs

Merck Cholesterol, Cancer Drugs Added to Voucher Program

FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Vouche...

Human Drugs

3D Imaging CGMP and Listing Violations

FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of positron emission tomogr...

Human Drugs

FDA Extends Review Timeline for Aldeyras Dry Eye Drug

FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye dise...

Guide to Increase Female Enrollment in Trials

FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.