Drugs.com - New Drug Approvals

FDA Approves Zevaskyn (prademagene zamikeracel) Gene Therapy for Patients with Recessive Dystrophic Epidermolysis Bullosa

FDA Approves Zevaskyn (prademagene zamikeracel) Gene Th...

May 12, 2025 0

CLEVELAND, April 29, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ...

FDA Approves Penpulimab-kcqx for the Treatment of Advanced Nasopharyngeal Carcinoma

FDA Approves Penpulimab-kcqx for the Treatment of Advan...

May 12, 2025 0

HONG KONG, April 24, 2025 -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") is...

Dupixent (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)

Dupixent (dupilumab) Approved in the U.S. as the First ...

May 12, 2025 0

TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmace...

U.S. Food and Drug Administration Updates Camzyos (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications

U.S. Food and Drug Administration Updates Camzyos (mava...

May 12, 2025 0

PRINCETON, N.J.-- April 17, 2025 -- (BUSINESS WIRE)-- Bristol Myers Squibb (NYS...

FDA Approves Mezofy (aripiprazole) Oral Film for the Treatment of Schizophrenia

FDA Approves Mezofy (aripiprazole) Oral Film for the Tr...

May 12, 2025 0

Seoul, Korea -- April 16, 2025 -- CMG Pharmaceuticals, an affiliate of Cha Biote...

FDA Grants Isturisa (osilodrostat) Expanded Indication ...

May 12, 2025 0

Milan, Italy and Bridgewater, NJ, April 16, 2025 – Today Recordati announced tha...

Neurelis Announces FDA Approval for Immediate Use Seizu...

May 12, 2025 0

San Diego, CA – April, 16, 2025 – Neurelis, Inc., today announced that the U.S. ...

Mirum’s Livmarli Now FDA Approved in Tablet Formulation

May 12, 2025 0

FOSTER CITY, Calif.--(BUSINESS WIRE) April 14, 2025 -- Mirum Pharmaceuticals, I...

FDA Grants Interchangeable Designation to Yuflyma (adal...

May 12, 2025 0

INCHEON, South Korea, April 14, 2025 /-- Celltrion, Inc. today announced that th...

FDA Approves Imaavy (nipocalimab-aahu) for the Treatment of Generalized Myasthenia Gravis (gMG)

FDA Approves Imaavy (nipocalimab-aahu) for the Treatmen...

May 12, 2025 0

SPRING HOUSE, Pa., (April 30, 2025) – Johnson & Johnson (NYSE: JNJ) today announ...

FDA Approves Atzumi (dihydroergotamine) Nasal Powder for the Acute Treatment of Migraine

FDA Approves Atzumi (dihydroergotamine) Nasal Powder fo...

May 12, 2025 0

DURHAM, N.C., April 30, 2025 /PRNewswire/ -- Satsuma Pharmaceuticals, Inc., a la...

ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label

ANI Pharmaceuticals Announces FDA Approval for Expansio...

May 12, 2025 0

BAUDETTE, Minn., March 14, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (N...

FDA Approves Novartis Radioligand Therapy Pluvicto for Earlier Use Before Chemotherapy in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer

FDA Approves Novartis Radioligand Therapy Pluvicto for ...

May 12, 2025 0

Basel, March 28, 2025 – Novartis announced today that the US Food and Drug Admin...

FDA Approves Avmapki Fakzynja Co-Pack (avutometinib capsules/defactinib tablets) for KRAS-Mutated Recurrent Low-Grade Serous Ovarian Cancer

FDA Approves Avmapki Fakzynja Co-Pack (avutometinib cap...

May 12, 2025 0

BOSTON--(BUSINESS WIRE)--May 8, 2025-- Verastem Oncology (Nasdaq: VSTM), a bioph...

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