FDA Related News

Human Drugs

Libtayo +Chemo Approved for Advanced Lung Cancer

FDA approves Regeneron Pharmaceuticals PD-1 inhibitor Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for the first-line tre...

7 Combination Product Guidances on the Way

Office of Combination Products director Thinh Nguyen says seven draft and final guidances affecting combination products should be published in the fi...

Federal Register

Guide on Early Studies on Cell/Gene Therapies

Federal Register notice: FDA makes available a final guidance entitled Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Ph...

Federal Register

Guide on Bioanalytical Method Validation

Federal Register notice: FDA posts a final guidance entitled M10 Bioanalytical Method Validation and Study Sample Analysis.

Human Drugs

GSK Blenrep Phase 3 Misses Primary Endpoint

A Phase 3 trial of GSKs accelerated-approved Blenrep (belantamab mafodotin) in patients with relapsed or refractory multiple myeloma fails to meet its...

Human Drugs

FDA Places Hold on Verve Hypercholesterolemia Drug

FDA slaps a clinical hold on a Verve Therapeutics IND for its VERVE-101 in patients with heterozygous familial hypercholesterolemia.

Human Drugs

Verrica Pharma Refiling NDA for VP-102

Verrica Pharmaceuticals says it is filing an NDA resubmission in the first quarter next year for VP-102 to treat molluscum contagiosum.

Federal Register

Device Postmarket Surveillance Info Collection

Federal Register notice: FDA sends to OMB an information collection extension entitled Postmarket Surveillance of Medical Devices 21 CFR Part 822.

Federal Register

Info Collection on FOIA Identity Certifications

Federal Register notice: FDA seeks comments on an information collection extension entitled Certification of Identity; Form FDA 3975 (OMB Control Numb...