FDA to Fast-Track 9 Experimental Drugs Under New Trump Program

Immusoft Receives FDA Fast Track Designation for ISP-001, a First-in-Class Engineered B Cell Therapy for MPS I

drugs.com - 21/Oct 20:10

SAN FRANCISCO, Oct. 21, 2025 /PRNewswire/ -- Immusoft of CA, a clinical-stage biotechnology company pioneering engineered B cell therapies, today...

FDA unveils drugs to receive expedited review in support of 'national priorities'

wn.com - 17/Oct 07:54

The Food and Drug Administration is announcing the first round of drugs that will receive drastically expedited reviews at the agency ......

Fast Track Granted by FDA for NNZ-2591 in Phelan-McDermid Syndrome

drugs.com - 20/Oct 19:10

Melbourne, Australia: 20 October 2025 Neuren Pharmaceuticals (ASX: NEU) today announced that the US Food and Drug Administration (FDA) has granted...

FDA Approves Expanded Pediatric Indications for Yuflyma (adalimumab-aaty)

drugs.com - 17/Oct 21:10

INCHEON, South Korea, Oct. 17, 2025 -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved expanded...

Top FDA Official Responds to Critics, Says Agency Not Stalling Approval of Good Drugs

wn.com - 20/Oct 20:32

One of the Food and Drug Administration’s top officials said in a new video that he is not blocking drugs that...

BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA

drugs.com - 15/Oct 04:10

SAN CARLOS, Calif.--(BUSINESS WIRE) October 13, 2025 -- BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today...

New Nonhormonal Drug, Lynkuet, Approved to Treat Menopause Symptoms

drugs.com - 27/Oct 15:10

MONDAY, Oct. 27, 2025 — The U.S. Food and Drug Administration (FDA) has approved a new nonhormonal treatment to help women manage menopause...

New Nonhormonal Drug, Lynkuet, Approved to Treat Menopause Symptoms

drugs.com - 27/Oct 15:10

MONDAY, Oct. 27, 2025 — The U.S. Food and Drug Administration (FDA) has approved a new nonhormonal treatment to help women manage menopause...

Trump Announces Lower-Cost Gonal-F Fertility Drug Deal With EMD Serono

drugs.com - 20/Oct 14:10

MONDAY, Oct. 20, 2025 — The Trump administration announced that Boston-based drugmaker EMD Serono will lower the price of one of its leading...

Syndax Announces FDA Approval of Revuforj (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia

drugs.com - 24/Oct 21:10

NEW YORK, Oct. 24, 2025 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative...

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FDA to Fast-Track 9 Experimental Drugs Under New Trump Program

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Immusoft Receives FDA Fast Track Designation for ISP-001, a First-in-Class Engineered B Cell Therapy for MPS I

FDA unveils drugs to receive expedited review in support of 'national priorities'

Fast Track Granted by FDA for NNZ-2591 in Phelan-McDermid Syndrome

FDA Approves Expanded Pediatric Indications for Yuflyma (adalimumab-aaty)

Top FDA Official Responds to Critics, Says Agency Not Stalling Approval of Good Drugs

BeOne Medicines’ Sonrotoclax Granted Breakthrough Therapy Designation by U.S. FDA

New Nonhormonal Drug, Lynkuet, Approved to Treat Menopause Symptoms

New Nonhormonal Drug, Lynkuet, Approved to Treat Menopause Symptoms

Trump Announces Lower-Cost Gonal-F Fertility Drug Deal With EMD Serono

Syndax Announces FDA Approval of Revuforj (revumenib) in Adult and Pediatric Patients with Relapsed or Refractory NPM1 Mutated Acute Myeloid Leukemia

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