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

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...

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...

FDA Expands Pediatric Indication for Rinvoq

drugs.com - 21/Jun 23:00

FRIDAY, June 21, 2024 -- The U.S. Food and Drug Administration has expanded indications for Rinvoq (upadacitinib) to now include pediatric patients...

Patritumab Deruxtecan BLA Submission Receives Complete Response Letter from FDA Due to Inspection Findings at Third-Party Manufacturer

drugs.com - 26/Jun 04:06

BASKING RIDGE, N.J. & RAHWAY, N.J., June 26, 2024 – The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)...

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)...

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...

AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)

drugs.com - 25/Jun 21:06

NORTH CHICAGO, Ill., June 25, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced it received a Complete Response Letter (CRL) from the U.S. Food...

FDA Approves Kisunla (donanemab-azbt) for the Treatment of Early Symptomatic Alzheimer's Disease

drugs.com - 02/Jul 19:07

INDIANAPOLIS, July 2, 2024 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) approved Kisunla™ (donanemab-azbt, 350 mg/20 mL...

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...

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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