Drugs.com - New Drug Approvals

Novartis Receives Third FDA Approval for Oral Fabhalta (iptacopan), the First and Only Treatment Approved in C3 Glomerulopathy

Novartis Receives Third FDA Approval for Oral Fabhalta ...

Mar 24, 2025 0

Basel, March 20, 2025 – Novartis today announced that oral Fabhalta (iptacopan) ...

FDA Approves Tremfya (guselkumab) for Adult Patients with Moderately to Severely Active Crohn’s Disease

FDA Approves Tremfya (guselkumab) for Adult Patients wi...

Mar 24, 2025 0

HORSHAM, Pa. (March 20, 2025) – Johnson & Johnson (NYSE: JNJ) today announced th...

Alnylam Announces FDA Approval of Amvuttra (vutrisiran), the First RNAi Therapeutic to Reduce Cardiovascular Death, Hospitalizations and Urgent Heart Failure Visits in Adults with ATTR Amyloidosis with Cardiomyopathy (ATTR-CM)

Alnylam Announces FDA Approval of Amvuttra (vutrisiran)...

Mar 24, 2025 0

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Mar. 20, 2025-- Alnylam Pharmaceuticals, Inc....

FDA Approves Pembrolizumab for HER2 Positive Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1 (CPS ≥1)

FDA Approves Pembrolizumab for HER2 Positive Gastric or...

Mar 24, 2025 0

On March 19, 2025, the Food and Drug Administration granted traditional approval...

FDA Approves Arbli (losartan potassium) Oral Suspension as the First Ready-to-Use Oral Liquid Losartan in the U.S.

FDA Approves Arbli (losartan potassium) Oral Suspension...

Mar 18, 2025 0

TAMPA, FL, March 18, 2025 (GLOBE NEWSWIRE) -- Scienture Holdings, Inc. NASDAQ: S...

ANI Pharmaceuticals Announces FDA Approval for Expansion of Iluvien Label

ANI Pharmaceuticals Announces FDA Approval for Expansio...

Mar 14, 2025 0

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

scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the Furoscix Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease

scPharmaceuticals Announces FDA Approval of Supplementa...

Mar 9, 2025 0

BURLINGTON, Mass., March 06, 2025 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Na...

FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair

FDA Approves Omlyclo (omalizumab-igec), an Interchangea...

Mar 7, 2025 0

March 07, 2025 -- Today, the U.S. Food and Drug Administration approved as the f...

FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel)

FDA Approves Encelto (revakinagene taroretcel-lwey) for...

Mar 7, 2025 0

CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private bi...

ARS Pharmaceuticals Announces FDA Approval of neffy 1 mg (epinephrine nasal spray) for Type I Allergic Reactions in Pediatric Patients

ARS Pharmaceuticals Announces FDA Approval of neffy 1 m...

Mar 6, 2025 0

SAN DIEGO, March 05, 2025 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals, Inc. (Nasdaq:...

Tevimbra Approved in U.S. for First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma in Combination with Chemotherapy

Tevimbra Approved in U.S. for First-line Treatment of A...

Mar 5, 2025 0

SAN MATEO, Calif.--(BUSINESS WIRE) Mar 04, 2025 -- BeiGene, Ltd. (NASDAQ: ONC; H...

FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia

FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to...

Mar 5, 2025 0

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that ...

FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva

FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to...

Mar 5, 2025 0

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that ...

FDA Approves TNKase (tenecteplase) for the Treatment of Acute Ischemic Stroke in Adults

FDA Approves TNKase (tenecteplase) for the Treatment of...

Mar 4, 2025 0

South San Francisco, CA -- March 3, 2025 -- Genentech, a member of the Roche Gro...

Indivior Announces FDA Approval of Label Changes for Sublocade (buprenorphine extended-release) Injection

Indivior Announces FDA Approval of Label Changes for Su...

Mar 3, 2025 0

Richmond, VA, February 24, 2025 – Indivior PLC (Nasdaq/LSE: INDV), a global lead...

FDA Approves Odactra for the Treatment of House Dust Mite Allergy in Young Children

FDA Approves Odactra for the Treatment of House Dust Mi...

Mar 1, 2025 0

February 27, 2025 -- ALK (ALKB:DC / OMX: ALK B) today announced that the US Food...

FDA Approves Miudella (copper intrauterine system) for the Prevention of Pregnancy

FDA Approves Miudella (copper intrauterine system) for ...

Feb 26, 2025 0

ROSWELL, GA, February 24, 2025 – Sebela Women’s Health Inc., a part of Sebela Ph...

FDA Approves Ctexli (chenodiol) for Cerebrotendinous Xanthomatosis

FDA Approves Ctexli (chenodiol) for Cerebrotendinous Xa...

Feb 24, 2025 0

February 21, 2025 -- Today, the U.S. Food and Drug Administration approved Ctexl...

FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog

FDA Approves Merilog (insulin-aspart-szjj), a Biosimila...

Feb 18, 2025 0

February 14, 2025 -- Today, the U.S. Food and Drug Administration approved Meril...

FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva

FDA Approves Xbryk (denosumab-dssb), a Biosimilar to Xgeva

Feb 17, 2025 0

INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that t...

FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to Prolia

FDA Approves Ospomyv (denosumab-dssb), a Biosimilar to ...

Feb 17, 2025 0

INCHEON, Korea – Feb 16, 2025 – Samsung Bioepis Co., Ltd. today announced that t...

FDA Approves Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for Prevention of Invasive Meningococcal Disease Caused by Serogroups A, B, C, W, and Y

FDA Approves Penmenvy (meningococcal groups A, B, C, W,...

Feb 17, 2025 0

London, UK - 15 February 2025 - GSK plc (LSE/NYSE: GSK) today announced that the...

FDA Approves Vimkunya (chikungunya vaccine, recombinant) for Prevention of Disease Caused by Chikungunya Virus

FDA Approves Vimkunya (chikungunya vaccine, recombinant...

Feb 17, 2025 0

COPENHAGEN, Denmark, February 14, 2025 – Bavarian Nordic A/S (OMX: BAVA) announc...

FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor

FDA Approves Romvimza (vimseltinib) for the Treatment o...

Feb 17, 2025 0

Osaka, Japan and Waltham, Massachusetts, February 14, 2025 – Ono Pharmaceutical ...

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