Drugs.com - New Drug Approvals

FDA Expands Xenoview Indication to Include Children From Six Years of Age

FDA Expands Xenoview Indication to Include Children Fro...

Jun 5, 2025 0

02 June 2025 -- Polarean Imaging plc (AIM: POLX), a commercial-stage medical ima...

U.S. FDA Approves Third Indication of Nubeqa (darolutamide) for Patients with Advanced Prostate cancer

U.S. FDA Approves Third Indication of Nubeqa (darolutam...

Jun 5, 2025 0

Berlin, June 3, 2025 – Bayer announced today that the U.S. Food and Drug Adminis...

FDA Approves mNEXSPIKE (COVID-19 Vaccine, mRNA) to Prevent COVID-19

FDA Approves mNEXSPIKE (COVID-19 Vaccine, mRNA) to Prev...

Jun 3, 2025 0

CAMBRIDGE, MA / ACCESS Newswire / May 31, 2025 / Moderna, Inc. (NASDAQ:MRNA) tod...

FDA Approves Khindivi (hydrocortisone) Oral Solution for Pediatric Patients with Adrenocortical Insufficiency

FDA Approves Khindivi (hydrocortisone) Oral Solution fo...

Jun 3, 2025 0

DEER PARK, Ill., May 28, 2025 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (“Et...

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution for the Treatment of Dry Eye Disease

FDA Approves Tryptyr (acoltremon) Ophthalmic Solution f...

May 29, 2025 0

GENEVA--(BUSINESS WIRE) May 28, 2025 -- Alcon (SIX/NYSE: ALC), the global leader...

FDA Approves Starjemza (ustekinumab-hmny), a Biosimilar to Stelara

FDA Approves Starjemza (ustekinumab-hmny), a Biosimilar...

May 28, 2025 0

Guangzhou and London – May 27, 2025 – Bio-Thera Solutions, Ltd (688177:SH), a co...

US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) Injection

US Food and Drug Administration (FDA) Grants Interchang...

May 28, 2025 0

INCHEON, Korea & JERSEY CITY, N.J.--(BUSINESS WIRE) May 27, 2025 -- Samsung Bioe...

FDA Approves Yutrepia (treprostinil) Inhalation Powder for Pulmonary Arterial Hypertension (PAH) and Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD)

FDA Approves Yutrepia (treprostinil) Inhalation Powder ...

May 27, 2025 0

MORRISVILLE, N.C., May 23, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ...

Arcutis’ Zoryve (roflumilast) Topical Foam 0.3% Approved by U.S. FDA for the Treatment of Plaque Psoriasis in Adults and Adolescents Ages 12 and Older

Arcutis’ Zoryve (roflumilast) Topical Foam 0.3% Approve...

May 27, 2025 0

WESTLAKE VILLAGE, Calif., May 22, 2025 (GLOBE NEWSWIRE) — Arcutis Biotherapeutic...

Celltrion's Yuflyma (adalimumab-aaty) Receives FDA Interchangeability Designation for All Approved Dosage Forms and Strengths

Celltrion's Yuflyma (adalimumab-aaty) Receives FDA Inte...

May 27, 2025 0

INCHEON, South Korea, May 23, 2025 /PRNewswire/ -- Celltrion, Inc. today announc...

FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

FDA Approves Genentech’s Susvimo for Diabetic Retinopathy

May 27, 2025 0

South San Francisco, CA -- May 22, 2025 -- Genentech, a member of the Roche Grou...

FDA Approves Brekiya (dihydroergotamine mesylate) Injection for the Acute Treatment of Migraine and Cluster Headaches in Adults

FDA Approves Brekiya (dihydroergotamine mesylate) Injec...

May 26, 2025 0

BRIDGEWATER, N.J., May 15, 2025 -- Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (...

U.S. FDA Grants Approval for Jivi (Antihemophilic Factor (Recombinant), PEGylated-aucl) in Pediatric Patients 7 to Under 12 Years of Age With Hemophilia A

U.S. FDA Grants Approval for Jivi (Antihemophilic Facto...

May 23, 2025 0

WHIPPANY, N.J.--(BUSINESS WIRE) May 19, 2025 --Bayer announced that the U.S. Foo...

Nucala (mepolizumab) Approved by US FDA for Use in Adults with Chronic Obstructive Pulmonary Disease (COPD)

Nucala (mepolizumab) Approved by US FDA for Use in Adul...

May 23, 2025 0

London, UK 22 May 2025 -- GSK plc (LSE/NYSE: GSK) today announced that the US Fo...

FDA Grants Interchangeable Designation to Fresenius Kabi’s Biosimilar Otulfi (ustekinumab-aauz)

FDA Grants Interchangeable Designation to Fresenius Kab...

May 21, 2025 0

LAKE ZURICH, Ill., May 19, 2025 – Fresenius Kabi, an operating company of Fresen...

FDA Approves Nuvaxovid (COVID-19 Vaccine, Adjuvanted) to Prevent COVID-19

FDA Approves Nuvaxovid (COVID-19 Vaccine, Adjuvanted) t...

May 21, 2025 0

GAITHERSBURG, Md., May 19, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) tod...

Shorla Oncology Announces FDA Approval of Tepylute 100mg, First and Only Ready-to-Dilute Multi-Dose Vial of Thiotepa

Shorla Oncology Announces FDA Approval of Tepylute 100m...

May 21, 2025 0

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Shorla Oncology (‘Shorla’), a U.S.-Ireland sp...

Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States

Incyte Announces FDA Approval of Zynyz (retifanlimab-dl...

May 20, 2025 0

WILMINGTON, Del.--(BUSINESS WIRE)--May 15, 2025-- Incyte (Nasdaq:INCY) today ann...

Teva and Alvotech Announce FDA Approval of Interchangeability for Selarsdi (ustekinumab-aekn) with Stelara (ustekinumab)

Teva and Alvotech Announce FDA Approval of Interchangea...

May 18, 2025 0

PARSIPPANY, N.J. & REYKJAVÍK, Iceland, May 05, 2025 (GLOBE NEWSWIRE) -- Teva Pha...

FDA Approves HemiClor (chlorthalidone) for the Treatment of Hypertension

FDA Approves HemiClor (chlorthalidone) for the Treatmen...

May 18, 2025 0

West Conshohocken, PA—April 16, 2025—PRM Pharma, LLC today announced the U.S. Fo...

FDA Approves Merck’s Welireg (belzutifan) for the Treatment of Adults and Pediatric Patients 12 Years and Older With Locally Advanced, Unresectable, or Metastatic Pheochromocytoma or Paraganglioma (PPGL)

FDA Approves Merck’s Welireg (belzutifan) for the Treat...

May 15, 2025 0

RAHWAY, N.J.--(BUSINESS WIRE) May 14, 2025 -- Merck (NYSE: MRK), known as MSD ou...

FDA Grants Accelerated Approval to Emrelis (telisotuzumab vedotin-tllv) for Non-Small Cell Lung Cancer With High c-Met Protein Overexpression

FDA Grants Accelerated Approval to Emrelis (telisotuzum...

May 15, 2025 0

NORTH CHICAGO, Ill., May 14, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today anno...

Xeris Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke VialDx™ (glucagon) for Use as a Diagnostic Aid

Xeris Announces Approval of Supplemental New Drug Appli...

May 13, 2025 0

CHICAGO--(BUSINESS WIRE)--Mar. 17, 2025-- Xeris Biopharma Holdings, Inc. (Nasdaq...

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

FDA Grants Accelerated Approval to Avmapki Fakzynja Co-...

May 13, 2025 0

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

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