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Maroc Maroc - DRUGS.COM - Pharma Industry News - 21/Jun 23:00

FDA Expands Pediatric Indication for Rinvoq

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has expanded indications for Rinvoq (upadacitinib) to now include pediatric patients (ages 2 years and older) with polyarticular juvenile idiopathic arthritis (pJIA) and psoriatic...

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FDA Approves PiaSky (crovalimab-akkz) for the Treatment of Paroxysmal Nocturnal Hemoglobinuria

drugs.com - 24/Jun 21:06

June 24, 2024 -- The U.S. Food and Drug Administration (FDA) has approved PiaSky (crovalimab-akkz) for the treatment of adult and pediatric patients...

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Harmony Biosciences Receives U.S. Food And Drug Administration Approval for Wakix (pitolisant) In Pediatric Patients With Narcolepsy

drugs.com - 24/Jun 23:06

PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration...

FDA expands orphan drug designation for Roswell Park's brain cancer immunotherapy

news.medical.net - 25/Jun 14:52

The U.S. Food and Drug Administration (FDA) has expanded orphan drug designation for SurVaxM, a brain cancer immunotherapy born in the labs of Roswell...

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Sarepta Therapeutics Announces Expanded US FDA Approval of Elevidys to Duchenne Muscular Dystrophy Patients Ages 4 and Above

drugs.com - 20/Jun 23:06

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 20, 2024-- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare...

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FDA Expands Approval for Duchenne Muscular Dystrophy Gene Therapy

drugs.com - 24/Jun 21:21

MONDAY, June 24, 2024 -- The U.S. Food and Drug Administration has expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene...

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Monthly News Roundup - June 2024

drugs.com - 30/Jun 00:06

FDA Grants Expanded Approval to Skyrizi for Ulcerative Colitis On June 18th, the U.S. Food and Drug Administration (FDA) approved AbbVie’s...

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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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FDA Approves KEYTRUDA + Chemo for Primary Advanced, Recurrent Endometrial Carcinoma

drugs.com - 21/Jun 22:55

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has approved Keytruda (pembrolizumab) plus chemotherapy as treatment for adult...

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FDA Approves Augtyro for NTRK-Positive Advanced Solid Tumors

drugs.com - 20/Jun 20:47

THURSDAY, June 20, 2024 -- The U.S. Food and Drug Administration has approved Augtyro (repotrectinib), a next-generation tyrosine kinase inhibitor...

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Bristol Myers Squibb Announces U.S. FDA Accelerated Approval of Krazati (adagrasib) in Combination with Cetuximab for Adult Patients with Previously Treated KRAS G12C-Mutated Locally Advanced or Metastatic Colorectal Cancer (CRC)

drugs.com - 21/Jun 20:06

PRINCETON, N.J.--(BUSINESS WIRE) June 21, 2024 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA)...