FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Celcuity Files sNDA for Revtorpyk Expanded Use

Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hormone receptor positive, human epidermal growth fac...

latest-news-card-1
Human Drugs

FDA OKs RevMeds Promising Pancreatic Cancer Drug

FDA approves Revolution Medicines Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer.

latest-news-card-1
Human Drugs

Comments on Expedited IND Pilot

Three stakeholders provide their responses to an FDA Request for Information on the Operation TrialBlazer Expedited IND Pilot Project.

latest-news-card-1

Device, Drug Recalls Down, Units Up

The Sedgwick Recall Index shows that in the first half of 2026, medical device and drug recalls fell, but the number of recalled units sharply increas...

latest-news-card-1
Biologics

Jemperli sBLA for Rectal Cancer Accepted for Priority Review

FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated Stage II and III loca...

latest-news-card-1
Human Drugs

Group Backs Circulating Tumor DNA as Early Endpoint

Friends of Cancer Research publishes two scientific articles it says demonstrate the value of circulating tumor DNA as an early endpoint in clinical t...

latest-news-card-1

R3 Selling Unapproved Drugs, Biologics, FDA Says

FDA warns Scottsdale, AZ-based R3 Medical Companies that its Bello Bio and Regen Suppliers units are selling unapproved drugs that are unlicensed biol...

latest-news-card-1
Biologics

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.

latest-news-card-1
Human Drugs

Create Unified Reference-Anchored Framework for Follow-Ons

Washington State University pharmacy professor Sarfaraz Niazi asks FDA to create an equivalence framework for follow-on human drugs and biologics.

latest-news-card-1
FDA General

Webinar on FDAs Bayesian Draft Guidance

FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.