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Bristol Myers' (BMY) Krazati Gets FDA Nod for Colorectal Cancer

zacks.com - 24/Jun 18:10

Bristol Myers (BMY) wins FDA approval for Krazati, in combination with Erbitux, as a targeted treatment option for adult patients with...

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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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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...

FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma

oncologynews.com.au - 01/Jul 16:26

On June 26, 2024, the Food and Drug Administration granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager,...

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Pharma Stock Roundup: FDA Nod to LLY's Kisunla, SNY's Dupixent Gets EU Nod for COPD

zacks.com - 05/Jul 14:16

Eli Lilly (LLY) wins FDA approval for its Alzheimer's disease drug, Kisunla. (donanemab). Sanofi (SNY) and Regeneron's Dupixent gets approval for COPD...

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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...

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FDA Rejects Rocket's (RCKT) Gene Therapy BLA for Rare Disease

zacks.com - 01/Jul 14:31

Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte...

The ASX biotechs with secured FDA clearances in 2024, and others looking likely

stockhead.com.au - 25/Jun 20:50

Approval from the FDA not only validates the safety and efficacy of a new drug, but also opens the door ...

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Eli Lilly (LLY) Gets FDA Nod for Alzheimer's Drug Donanemab

zacks.com - 03/Jul 12:34

Eli Lilly's (LLY) Alzheimer's disease drug, Kisunla (donanemab), wins FDA approval. Kisunla will be the second drug on the market to treat the...