FDA Approves TNKase for Acute Ischemic Stroke

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

drugs.com - 03/Mar 22:03

South San Francisco, CA -- March 3, 2025 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food...

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

drugs.com - 06/Mar 22:03

CUMBERLAND, R.I.--(BUSINESS WIRE)--Neurotech Pharmaceuticals, Inc., a private biotech company focused on developing transformative therapies for...

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

drugs.com - 03/Mar 00:03

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Stoboclo...

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

drugs.com - 03/Mar 00:03

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved Osenvelt...

FDA approves treosulfan with fludarabine as a preparative regimen for alloHSCT in adult and paediatric patients with AML or MDS

oncologynews.com.au - 23/Feb 15:06

On January 21, 2025, the Food and Drug Administration approved treosulfan, an alkylating agent, with fludarabine as a preparative regimen for...

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

drugs.com - 07/Mar 22:03

March 07, 2025 -- Today, the U.S. Food and Drug Administration approved as the first interchangeable biosimilar to Xolair (omalizumab). Omlyclo, like...

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

drugs.com - 28/Feb 23:02

February 27, 2025 -- ALK (ALKB:DC / OMX: ALK B) today announced that the US Food and Drug Administration (FDA) has approved ALK’s Odactra tablet...

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

drugs.com - 24/Feb 23:02

Richmond, VA, February 24, 2025 – Indivior PLC (Nasdaq/LSE: INDV), a global leader in addiction treatment, today announced that the U.S. Food...

FDA Expands Indication of Dust Mite Allergy Drug to Include Young Children

drugs.com - 05/Mar 22:08

WEDNESDAY, March 5, 2025 -- The U.S. Food and Drug Administration has expanded its indication of Odactra, a house dust mite allergen tablet, for the...

US FDA grants fast track designation to Latigo Biotherapeutics' LTG─001, an oral, investigational selective Nav1.8 inhibitor for the treatment of acute pain

pharmabiz.com - 04/Mar 23:54

Latigo Biotherapeutics (Latigo), a private clinical─stage biotechnology company, announced the US Food and Drug Administration (FDA) has granted...

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