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...

Microvascular Tissue Marketing Unapproved New Drug

FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug that is also an unl...

FDA General

FDA Commissioner Defends Vaccine Stance, Transparency Push

In a recent interview, FDA commissioner Marty Makary positions himself as a supporter of vaccines while defending recent agency actions that have draw...

Biologics

Makary Says No Plans for Covid Vaccine Boxed Warning

FDA commissioner Marty Makary says the agency has no plans to add a Black Box Warning to Covid vaccines, contradicting a report from last week saying ...