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Pfizer wins FDA approval for its $7B colitis drug

BioPharma Drive: Drug Pricing

Acquired with the buyout of Arena Pharmaceuticals, Velsipity enters a competitive market for ulcerative colitis pills.

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FDA Approves First New Non-Opioid Pain Pill in Decades

Drugs.com

Food and Drug Administration (FDA) has approved Journavx, a new pain reliever without the risks of addiction or overdose linked to drugs like Vicodin and OxyContin.The new pill, developed by Vertex Pharmaceuticals.

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Binghamton researchers get FDA approval for drug to treat world’s most common genetic disease

SCIENMAG: Medicine & Health

— A new drug developed by professors from the School of Pharmacy and Pharmaceutical Sciences at Binghamton University has received Food and Drug Administration (FDA) approval for the treatment of patients with Duchenne muscular dystrophy (DMD), a common genetic disease that mostly affects young boys. BINGHAMTON, N.Y.

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The Regulatory Maze: How Generic Drugs Navigate FDA Approval

Drug Patent Watch

In the high-stakes world of pharmaceuticals, generic drugs have become the unsung heroes of healthcare accessibility. These cost-effective alternatives to […] Source

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Fitusiran

New Drug Approvals

2] Fitusiran was approved for medical use in the United States in March 2025. [2] 2] The fixed dose of fitusiran is not approved because it led to excessive clotting in some participants. [2] 2] The US Food and Drug Administration (FDA) granted the application for fitusiran orphan drug and fast track designations. 26 March 2025.

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Jazz Pharma Unveils Late-Stage Xywav® Data in Narcolepsy at SLEEP 2025

The Pharma Data

Xywav: A Low-Sodium Alternative with FDA Approval Xywav is a uniquely formulated, low-sodium oxybate therapy, and remains the only product of its kind approved by the U.S. It is also approved for adult patients with idiopathic hypersomnia (IH). Source link

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Gepirone

New Drug Approvals

2] Gepirone was synthesized by Bristol-Myers Squibb in 1986 and was developed and marketed by Fabre-Kramer Pharmaceuticals. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 12] However, in March 2016, the FDA reversed its decision and gave gepirone ER a positive review.

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