Drugs.com - New Drug Approvals

Neurelis Announces FDA Approval for Immediate Use Seizure Medication Valtoco (diazepam nasal spray) in Ages 2 to 5 Years

Neurelis Announces FDA Approval for Immediate Use Seizu...

Apr 17, 2025 0

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

FDA Approves an Updated Label for Tryvio (aprocitentan) Removing the REMS Requirement

FDA Approves an Updated Label for Tryvio (aprocitentan)...

Apr 16, 2025 0

Allschwil, Switzerland – April 9, 2025 Idorsia Ltd (SIX: IDIA) today announced t...

FDA Grants Interchangeable Designation to Yuflyma (adalimumab-aaty), Celltrion's Biosimilar to Humira (adalimumab)

FDA Grants Interchangeable Designation to Yuflyma (adal...

Apr 15, 2025 0

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

FDA Approves Jobevne (bevacizumab-nwgd), a Biosimilar to Avastin

FDA Approves Jobevne (bevacizumab-nwgd), a Biosimilar t...

Apr 15, 2025 0

BRIDGEWATER, New Jersey and BENGALURU, Karnataka, India, April 10, 2025 -- Bioco...

Mirum’s Livmarli Now FDA Approved in Tablet Formulation

Mirum’s Livmarli Now FDA Approved in Tablet Formulation

Apr 15, 2025 0

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

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as a First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) a...

Apr 14, 2025 0

PRINCETON, N.J.--(BUSINESS WIRE) April 11, 2025 -- Bristol Myers Squibb (NYSE: ...

Argenx Announces FDA Approval of Vyvgart Hytrulo Prefilled Syringe for Self-Injection

Argenx Announces FDA Approval of Vyvgart Hytrulo Prefil...

Apr 14, 2025 0

April 10, 2025 -- argenx SE (Euronext & Nasdaq: ARGX), a global immunology compa...

U.S. FDA Grants Full Approval of Vitrakvi (larotrectinib) for Adult and Pediatric Patients with NTRK Gene Fusion-Positive Solid Tumors

U.S. FDA Grants Full Approval of Vitrakvi (larotrectini...

Apr 14, 2025 0

WHIPPANY, N.J.--(BUSINESS WIRE) April 10, 2025 --Bayer today announced that the ...

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as a Treatment for Patients with Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable or Metastatic Colorectal Cancer

FDA Approves Opdivo (nivolumab) + Yervoy (ipilimumab) a...

Apr 14, 2025 0

PRINCETON, N.J.--(BUSINESS WIRE)-- Apr 08, 2025 -- Bristol Myers Squibb (NYSE: ...

Uplizna (inebilizumab-cdon) is Now the First and Only FDA-Approved Treatment for IgG4-Related Disease

Uplizna (inebilizumab-cdon) is Now the First and Only F...

Apr 14, 2025 0

THOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announc...

U.S. Food and Drug Administration Approves Opdivo (nivolumab) plus Yervoy (ipilimumab) as a Treatment for Patients with Previously Untreated Microsatellite Instability-High or Mismatch Repair Deficient Unresectable or Metastatic Colorectal Cancer

U.S. Food and Drug Administration Approves Opdivo (nivo...

Apr 14, 2025 0

PRINCETON, N.J.--(BUSINESS WIRE)-- Apr 08, 2025 -- Bristol Myers Squibb (NYSE: ...

FDA Grants Accelerated Approval for Vanrafia (atrasentan) for Proteinuria Reduction in Primary IgA Nephropathy

FDA Grants Accelerated Approval for Vanrafia (atrasenta...

Apr 4, 2025 0

Basel, April 3, 2025 – Novartis today announced the US Food and Drug Administrat...

Bavarian Nordic Receives U.S. FDA Approval of Jynneos Freeze-Dried Smallpox and Mpox Vaccine

Bavarian Nordic Receives U.S. FDA Approval of Jynneos F...

Apr 1, 2025 0

COPENHAGEN, Denmark, March 31, 2025 – Bavarian Nordic A/S (OMX: BAVA) today anno...

FDA Approves Expanded Use of Soliris (eculizumab) for Pediatric Myasthenia Gravis, Bringing New Treatment Options for Children

FDA Approves Expanded Use of Soliris (eculizumab) for P...

Mar 31, 2025 0

New York, March 10, 2025 – The Muscular Dystrophy Association (MDA) welcomes the...

FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A or B With or Without Inhibitors

FDA Approves Qfitlia (fitusiran) to Treat Hemophilia A ...

Mar 30, 2025 0

Paris, March 28, 2025. The US Food and Drug Administration (FDA) has approved Qf...

FDA Approves Bomyntra (denosumab-bnht), a Biosimilar to Xgeva

FDA Approves Bomyntra (denosumab-bnht), a Biosimilar to...

Mar 29, 2025 0

LAKE ZURICH, Ill., March 27, 2025 -- Fresenius announced that the Biologics Lice...

FDA Approves Conexxence (denosumab-bnht), a Biosimilar to Prolia

FDA Approves Conexxence (denosumab-bnht), a Biosimilar ...

Mar 29, 2025 0

LAKE ZURICH, Ill., March 27, 2025 -- Fresenius announced that the Biologics Lice...

FDA Approves Imfinzi (durvalumab) for Muscle Invasive Bladder Cancer

FDA Approves Imfinzi (durvalumab) for Muscle Invasive ...

Mar 29, 2025 0

On March 28, 2025, the Food and Drug Administration approved durvalumab (Imfinzi...

Theratechnologies Receives FDA Approval for Egrifta WR (tesamorelin F8) to Treat Excess Visceral Abdominal Fat in Adults with HIV and Lipodystrophy

Theratechnologies Receives FDA Approval for Egrifta WR ...

Mar 29, 2025 0

MONTREAL, March 25, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechn...

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 ...

Mar 29, 2025 0

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

FDA Approves Vykat XR (diazoxide choline) to Treat Hyperphagia in Prader-Willi Syndrome

FDA Approves Vykat XR (diazoxide choline) to Treat Hype...

Mar 27, 2025 0

REDWOOD CITY, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, In...

Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) for Patients with Previously Treated Advanced Neuroendocrine Tumors

Exelixis Announces U.S. FDA Approval of Cabometyx (cabo...

Mar 26, 2025 0

ALAMEDA, Calif.--(BUSINESS WIRE)--Mar. 26, 2025-- Exelixis, Inc. (Nasdaq: EXEL) ...

FDA Approves Blujepa (gepotidacin) for the Treatment of Uncomplicated Urinary Tract Infections

FDA Approves Blujepa (gepotidacin) for the Treatment of...

Mar 25, 2025 0

London, UK -- 25 March 2025 -- GSK plc (LSE/NYSE: GSK) today announced that the ...

FDA Approves Gozellix (kit for the preparation of gallium Ga 68 gozetotide injection) for Prostate Cancer Imaging

FDA Approves Gozellix (kit for the preparation of galli...

Mar 24, 2025 0

Melbourne Australia | 21 March 2025 -- Telix today announces that the United Sta...

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