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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...

Imricor starts global trial for US FDA approval

stockhead.com.au - 21/Jun 04:48

Imricor’s VISABL-AFL global clinical trial supporting US  Food  and  Drug  Administration  (FDA)  approval has kicked off. ...

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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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Genting and TauRx applying for UK, US regulators' approval for Alzheimer's drug

nst.com.my - 20/Jun 21:55

KUALA LUMPUR: Genting Bhd, along with its partner TauRx Pharmaceuticals Ltd., is currently seeking approval from both the United Kingdom's Medicines...

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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)...

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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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 Converts Tuberculosis Treatment Sirturo to Traditional Approval

drugs.com - 21/Jun 23:06

On June 21, 2024, the FDA converted Sirturo (bedaquiline) from accelerated approval to traditional approval following a determination that a...