FDA to Investigate Safety of Toxic Metals in Tampons

FDA Accepts New Drug Application and Grants Priority Review for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent

drugs.com - 24/Oct 03:10

Melbourne (Australia) | 24 October 2024 -- Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the New...

Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE

drugs.com - 04/Nov 23:11

CARLSBAD, Calif., Nov. 4, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced today that the U.S. Food and Drug Administration...

Shorla Oncology Announces U.S. FDA Expanded Approval of Jylamvo (methotrexate), an Oncology and Autoimmune Drug for Pediatric Indications

drugs.com - 29/Oct 10:10

CAMBRIDGE, Mass.--(BUSINESS WIRE) October 29, 2024 --Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company,...

PTC Therapeutics Announces FDA Acceptance of Translarna NDA Resubmission

drugs.com - 30/Oct 05:10

WARREN, N.J., Oct. 30, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) has...

FDA recalls antidepressant after finding cancerous chemical

washingtontimes.com - 25/Oct 15:59

The U.S. Food and Drug Administration issued a recall this week affecting thousands of bottles of duloxetine, an antidepressant sold under the name...

FDA Approves Orlynvah (sulopenem etzadroxil and probenecid) for the Treatment of Uncomplicated Urinary Tract Infections

drugs.com - 25/Oct 21:10

DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug...

FDA Grants Rare Pediatric Disease Designation to Omeros’ MASP-3 Inhibitor Zaltenibart for Treatment of C3 Glomerulopathy

drugs.com - 24/Oct 23:10

SEATTLE--(BUSINESS WIRE)--Oct. 24, 2024-- Omeros Corporation today announced that zaltenibart (OMS906) has received rare pediatric disease designation...

Abeona Therapeutics Completes Pz-cel Biologics License Application Resubmission to U.S. Food and Drug Administration

drugs.com - 29/Oct 22:10

CLEVELAND, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced that the Company has resubmitted its Biologics...

Camurus Provides Regulatory Update on the US NDA for CAM2029 in Acromegaly

drugs.com - 22/Oct 20:10

Lund, Sweden — 22 October 2024 — Camurus (NASDAQ STO: CAMX) today announced that the U.S. Food and Drug Administration (FDA) has issued a...

FDA Appoints New Head of Medical Devices

drugs.com - 23/Oct 15:10

WEDNESDAY, Oct. 23, 2024 -- The U.S. Food and Drug Administration announced Tuesday that it has appointed Dr. Michelle Tarver to head its division...

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