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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

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).

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Evolved Ayurvedic Discoveries and AcelRx Pharmaceuticals.

Medical Devices

FDA OKs Shockwave Coronary Artery Plaque Buster

FDA approves a Shockwave Medical PMA for its Intravascular Lithotripsy to treat severely calcified coronary artery disease.

Biologics

Bluebird Bio Suspends 2 Gene Therapy Studies

Bluebird Bio temporarily suspends studies of LentiGlobin gene therapy for sickle cell disease due to a reported unexpected serious adverse reaction.

Medical Devices

FDA, DARPA Push Trustworthy Hardware

FDA cybersecurity advisor Jessica Wilkerson urges security controls wherever they can be built into hardware and software.