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Maroc Maroc - DRUGS.COM - New Drug Applications - 01/Jul 06:07

SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has completed the submission...

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SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

zacks.com - 02/Jul 16:12

SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with...

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SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

zacks.com - 02/Jul 16:12

SpringWorks (SWTX) completes the submission of a new drug application for its MEK inhibitor, mirdametinib, for treating patients with...

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SELLAS Announces U.S. FDA Rare Pediatric Disease Designation Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia

drugs.com - 24/Jun 23:06

NEW YORK, June 24, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS” or the “Company”), a...

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Veru to Participate in the Leerink Therapeutics Forum: I&I and Metabolism

mangaloremirror.com - 02/Jul 12:51

MIAMI, FL, July 02, 2024 (GLOBE NEWSWIRE) — Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing...

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FDA Approves Ohtuvayre (ensifentrine) for the Maintenance Treatment of Chronic Obstructive Pulmonary Disease (COPD)

drugs.com - 26/Jun 21:06

LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) — Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the...

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Synaptogenix gets US FDA authorization of IND application for clinical trial for Bryostatin─1 to treat multiple sclerosis

pharmabiz.com - 01/Jul 00:00

Synaptogenix, Inc., an emerging biopharmaceutical company developing therapeutics for neurodegenerative disorders, announced that the Food & Drug...

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Spectral AI Achieves 100% Pediatric Enrollment in Burn Centers for Pivotal U.S. Burn Study

mangaloremirror.com - 02/Jul 12:02

DALLAS, July 02, 2024 (GLOBE NEWSWIRE) — Spectral AI, Inc. (Nasdaq: MDAI) (“Spectral AI” or the “Company”), an artificial intelligence...

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Epkinly (epcoritamab-bysp) Approved by U.S. FDA for Patients with Relapsed or Refractory (R/R) Follicular Lymphoma (FL)

drugs.com - 27/Jun 04:06

COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved...

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Vertex Announces FDA Acceptance of New Drug Application for Vanzacaftor/Tezacaftor/Deutivacaftor, a Next-In-Class Triple Combination Treatment for Cystic Fibrosis

mangaloremirror.com - 02/Jul 12:37

– Vanza triple granted priority review with Prescription Drug User Fee Act (PDUFA) target action date of January 2, 2025 – – EU...

New Alzheimer's treatment approved by FDA

poandpo.com - 05/Jul 03:52

The U.S. Food and Drug Administration (FDA) has approved a new Alzheimer's treatment from American pharmaceutical company Eli Lilly. The U.S....