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Human Drugs

10 Companies Warned Over Diabetes Dietary Supplements

FDA and the Federal Trade Commission warn 10 companies that they are illegally marketing drugs to treat diabetes as dietary supplements.

Human Drugs

Congress Must Regulate CBD Since FDA Wont: Steve Mister

Council for Responsible Nutrition CEO Steve Mister says Congress must regulate the cannabidiol market since FDA is unwilling to.

Human Drugs

ICU Medical Recalls Aminosyn II

ICU Medical recalls one lot of Aminosyn II, 15% (amino acid injection) sulfite-free intravenous solution due to the presence of visible particulate ma...

Human Drugs

Robust Responses in Moderna Covid Booster

Moderna says a Phase 2 trial shows a robust response to a third or booster shot of its Covid-19 mRNA vaccine.

Human Drugs

Myfembree sNDA for Endometriosis Pain

FDA accepts for review a Myovant Sciences and Pfizer supplemental NDA for Myfembree for managing moderate to severe pain associated with endometriosis...

Human Drugs

Apellis Pharma Plan NDAs for Geographic Atrophy

Apellis Pharmaceuticals says it plans to file an NDA in the first half of 2022 after reporting top-line results from the Phase 3 DERBY and OAKS studie...

FDA General

Hahn is YourBio Health Interim Chief Medical Officer

YourBio Health names former FDA commissioner Stephen Hahn as its interim chief medical officer.

Federal Register

Tobacco Scientific Panel Members Sought

Federal Register notice: FDA seeks nominations for members to serve on the Tobacco Products Scientific Advisory Committee.

Federal Register

Proposals Sought for Drug Excipient Pilot

Federal Register notice: CDER announces its Novel Excipient Review Pilot Program and seeks initial proposals by 12/7.

Human Drugs

Azurity Pharma Recalls 1 Firvanq Lot

Azurity Pharmaceuticals recalls one lot of Firvanq (vancomycin hydrochloride for oral solution) 50 mg/mL kit because some products in the affected lot...