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10 Companies Warned Over Diabetes Dietary Supplements

[ Price : $8.95]

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

Congress Must Regulate CBD Since FDA Wont: Steve Mister

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

ICU Medical Recalls Aminosyn II

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

Robust Responses in Moderna Covid Booster

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

Myfembree sNDA for Endometriosis Pain

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

Apellis Pharma Plan NDAs for Geographic Atrophy

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

Tobacco Scientific Panel Members Sought

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

Proposals Sought for Drug Excipient Pilot

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

Azurity Pharma Recalls 1 Firvanq Lot

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

More Research Needed on Multiple Myeloma PRO Data: CDER

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CDER researchers say that more research is needed to determine the most appropriate approaches for statistical and analytical meth...