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Human Drugs

Pfizer Licenses Investigational Antisense Therapy

Pfizer licenses Akcea Therapeutics Akcea-AngPtl3-L, an investigational antisense therapy being developed for certain cardiovascular and metabolic dise...

Human Drugs

Pfenex NDA Approved for Forteo Copy

FDA approves a Pfenex Inc. 505(b)(2) NDA for PF708 (teriparatide injection) that referenced Eli Lillys Forteo, indicated for treating osteoporosis.

Human Drugs

Galderma Novel Topical OKd for Acne

FDA approves a Galdermas Aklief (trifarotene) Cream for topically treating acne.

Human Drugs

Mereo BioPharma Fast Track for Cancer

FDA grants Mereo BioPharma Group fast track status for navicixizumab and its use for treating high grade ovarian, primary peritoneal or fallopian tube...

Medical Devices

ProTom Radiance 330 Proton System Cleared

FDA clears a ProTom International Holding 510(k) for its Radiance 330 proton therapy system.

FDA General

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/4/2019.

FDA General

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 10/4/2019.

Federal Register

Panel to Review Jardiance sNDA

Federal Register notice: FDA announces an 11/13 Endocrinologic and Metabolic Drugs Advisory Committee meeting to review a Boehringer Ingelheim supplem...

Human Drugs

FDA Funding for Drug Safe Use Research

As part of FDAs Safe Use Initiative, CDER director Janet Woodcock announces a funding opportunity for individuals and organizations to conduct further...

FDA General

FDA Warns Against Vaping THC as Injuries Rise

FDA updates a consumer alert to warn against using vaping products containing THC as the latest number of reported cases and deaths associated with va...