FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Medical Devices

Some Medical Gloves Removed From Shortage List

FDA updates its device shortage list to remove medical gloves (product codes LYY, LYZ, LZA, and LZC) that were in short supply due to the Covid-19 pan...

latest-news-card-1
Human Drugs

Panel Meeting to Discuss Isotretinoin iPLEDGE REMS Program

FDA announces a 3/28-29/2023 advisory committee meeting to discuss proposed changes to the iPLEDGE Risk Evaluation and Mitigation Strategy for acne dr...

latest-news-card-1
Human Drugs

FDA Hits 2 QuVA Pharma Facilities with 483s

FDA releases two Form FDA-483s after inspecting QuVa Pharma outsourcing facilities in New Jersey and Texas.

latest-news-card-1
Federal Register

Dear Doctor Letters Information Collection

Federal Register notice: FDA sends to OMB an information collection extension entitled Improving Communication of Important Safety Information 21 CFR...

latest-news-card-1
Human Drugs

Mirati Gets Accelerated OK for Lung Cancer Drug

FDA grants accelerated approval to Mirati Therapeutics for its Krazati (adagrasib) NDA, indicated for treating adult patients with KRAS G12C-mutated l...

Human Drugs

FDA Sets BsUFA Goal Date for Alvotechs Humira Biosimilar

Icelands Alvotech says it expects an FDA decision on its BLA for a Humira biosimilar on 4/13.

Human Drugs

Address Prescription Adderall Shortage: Spanberger

Rep. Abigail Spanberger asks FDA and the DEA how they will work together and independently to overcome the current shortage of Adderall.

Human Drugs

Green Pharmaceuticals SnoreStop Adulterated: FDA

FDA warns Camarillo, CA-based Green Pharmaceuticals that it is distributing an adulterated unapproved new drug.

Human Drugs

Madrigals Resmetirom Hits Phase 3 NASH Endpoints

Madrigal Pharmaceuticals says its resmetirom met FDA-suggested endpoints in the pivotal Phase 3 MAESTRO-NASH trial to treat nonalcoholic steatohepatit...

Medical Devices

Empowered Diagnostics Unapproved Covid Tests

FDA warns Pompano Beach, FL-based Empowered Diagnostics about illegally manufacturing and distributing Covid-19 tests.