FDA Related News

Medical Devices

510(k) Guidances for 2 Ultrasound-type Devices Published

FDA publishes two 510(k) guidances on ultrasound and related types of devices.

Human Drugs

Intarcia Agrees to Advisory Committee to Resolve Review Dispute

Intarcia Therapeutics accepts an FDA proposal to allow an advisory committee to review and address a 2021 CDER decision not to approve the companys Ty...

Federal Register

Lagevrio Misses Endpoint in Covid-19 Study

Merck says a study of its Covid-19 drug Lagevrio (molnupiravir) did not meet the primary endpoint a statistically significant risk reduction in those...

Human Drugs

Regulatory Agenda Eyes DTC Ads and Med Guides

HHS publishes its semiannual regulatory agenda that outlines numerous FDA rulemaking activities under development, including a final rule on DTC Rx dr...

Human Drugs

FDA OKs Chiesis Lamzede for Alpha-Mannosidosis

FDA approves Chiesis Lamzede to treat some manifestations of alpha-mannosidosis in adults and children.

Federal Register

FDA Withdraws Miles Laboratories ANDA

Federal Register notice: FDA withdraws a Miles Laboratories ANDA for alcohol and dextrose injection, 5 mL/100 mL because the agency has scientific dat...

Human Drugs

Product-Specific Guidance Meetings

FDA publishes a draft guidance with information on requesting and conducting product-specific guidance meetings between FDA and ANDA applicants.

Califf Sees Misinformation as Cause of Preventable Deaths

FDA commissioner Robert Califf announces a project to explore ways the agency can respond to and counter misleading health information in a variety of...

Medical Devices

Zephyrus Safety Syringe Cleared

FDA clears a Zephyrus Innovations 510(k) for its Aerojec 3ml safety syringe.

Human Drugs

FDA OKs Apellis Syfovre for Geographic Atrophy

FDA approves Apellis Pharmaceuticals Syfovre to treat geographic atrophy secondary to age-related macular degeneration.