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Human Drugs

Woodcock Rejects Public Citizen Firewall Proposal

FDA acting commissioner Janet Woodcock defends the integrity of the agencys drug review processes and rejects a Public Citizen proposal for a firewall...

Human Drugs

Amgen NDA Gets Priority Review for Lung Cancer

FDA accepts for priority review an Amgen NDA for sotorasib for treating certain patients with KRAS G12C-mutated locally advanced or metastatic non-sma...

Human Drugs

Verrica Pharma Resubmits NDA for Molluscum Drug

Verrica Pharmaceuticals resubmits its NDA for VP-102 (cantharidin 0.7% topical solution), a proprietary topical therapy for treating molluscum contagi...

Medical Devices

FDA OKs Axonics Implantable Neurostimulator PMA

FDA approves an Axonics Modulation Technologies PMA for its third-generation implantable neurostimulator.

Biologics

FDA Accepts Coherus Bio BLA for Humira Biosimilar

FDA accepts for review a Coherus BioSciences BLA for CHS-1420, a biosimilar to AbbVies Humira (adalimumab).

Federal Register

Joint Panel to Review Pfizer Osteoarthritis BLA

Federal Register notice: FDA has announced a 3/24 joint meeting of the Arthritis and the Drug Safety and Risk Management Advisory Committees to discus...

Federal Register

Vaccines Panel to Discuss Influenza Seasonal Strains

Federal Register notice: FDA announces a 3/5 Vaccines and Related Biological Products Advisory Committee meeting to discuss 2021 to 2022 influenza vac...

Federal Register

Device Panel to Mull Dermal Fillers

Federal Register notice: FDA announces a 3/23 Medical Devices Advisory Committees General and Plastic Surgery Devices Panel meeting that will discuss ...

Human Drugs

Evolved Ayurvedic Discoveries Selling Unapproved CBD Products: FDA

FDA warns Evolved Ayuverdic Discoveries that its BioCBD+ products are legally considered to be misbranded unapproved new drugs.

Human Drugs

False or Misleading Dsuvia Claims in Professional Promotion: OPDP

The CDER Office of Prescription Drug Promotion warns AcelRx about false or misleading statements about its Dsuvia included in professional promotional...