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Maroc Maroc - DRUGS.COM - Pharma Industry News - 15/Aug 22:00

FDA Approves Nemluvio for Prurigo Nodularis

THURSDAY, Aug. 15, 2024 -- The U.S. Food and Drug Administration has approved Nemluvio (nemolizumab) for adult patients living with prurigo nodularis.Nemluvio, administered as a prefilled pen for subcutaneous injection, inhibits interleukin-31...

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FDA Approves Vyalev for Advanced Parkinson Disease

drugs.com - 22/Oct 22:45

TUESDAY, Oct. 22, 2024 -- The U.S. Food and Drug Administration has approved Vyalev (foscarbidopa and foslevodopa) for adults living with advanced...

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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...

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U.S. FDA Approves Pfizer’s RSV Vaccine Abrysvo for Adults Aged 18 to 59 at Increased Risk for Disease

drugs.com - 22/Oct 05:10

NEW YORK--(BUSINESS WIRE) October 22, 2024 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved...

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FDA Approves Vyloy for Advanced Gastric or Gastroesophageal Junction Cancer

drugs.com - 23/Oct 14:10

WEDNESDAY, Oct. 23, 2024 -- The U.S. Food and Drug Administration has approved Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and...

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Monthly News Roundup - October 2024

drugs.com - 31/Oct 00:10

FDA Approves AbbVie’s Vyalev to Treat Advanced Parkinson Disease In October, the US Food and Drug Administration (FDA) approved Vyalev...

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Novartis Scemblix Granted FDA Accelerated Approval in Newly Diagnosed CML

drugs.com - 29/Oct 10:10

East Hanover, October 29, 2024 – Novartis announced today that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug...

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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,...

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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...

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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...

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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...