Amgen gets expanded FDA label approval for Uplizna
Amgen (NASDAQ: NASDAQ:AMGN) announced that the U.S. Food and Drug Administration (FDA) has granted an expanded label approval ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...
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SNY's Rilzabrutinib Gets FDA's Orphan Drug Tag for Two Rare Diseases
Sanofi SNY announced that the FDA has granted orphan drug designation to its investigational BTK inhibitor, rilzabrutinib, for the treatment of warm autoimmune hemolytic anemia (wAIHA) and ...
Endovascular Today10d
Vasorum’s Celt ACD Plus Vascular Closure Device Approved by FDA
Vasorum USA, Inc. announced FDA approval of the Celt ACD Plus system, which is designed for rapid arterial puncture closure ...
MarketWatch16d
Telix Pharmaceuticals' New Drug Application for Prostate Imaging Drug Gets FDA Approval
Telix Pharmaceuticals' said its new drug application in the U.S. for an imaging agent received regulatory approval. The Melbrourne, Australia-based biopharmaceutical company said Friday that the ...
Nasdaq17d
Glenmark Gets FDA Approval For Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC)
(RTTNews) - Glenmark Pharmaceuticals Inc., USA announced that it has received final approval from the U.S. Food & Drug Administration (FDA) for its Olopatadine Hydrochloride Ophthalmic Solution ...
MarketWatch17d
Alnylam's Amvuttra Gets Approval for Expanded Indication From FDA
Alnylam Pharmaceuticals' amyloidosis drug Amvuttra received Food and Drug Administration approval for an expanded indication. The drug was approved for treatment of the cardiomyopathy of wild-type ...
Nasdaq17d
FDA Approves Novartis' Oral Fabhalta For Treatment Of Adults With Complement 3 Glomerulopathy
Regulatory reviews for this indication are ongoing in China and Japan. Fabhalta received its first FDA approval in December 2023 for the treatment of adults with paroxysmal nocturnal ...
Seeking Alpha17d
Jumping Into The FDA Gamble: Initiating Hims & Hers With A Buy
I'm eyeing it as a favorable high-risk, high-reward play. HIMS stock plummeted after the FDA halted approval of its top-selling GLP-1 weight loss drug, which is priced at $165 and offers the same ...
The Hindu17d
Defence Acquisition Council gives initial approval for ₹54,000 crore military hardware purchases, norms to cut down procurement timelines
The Defence Acquisition Council (DAC) on Thursday (March 20, 2025) approved guidelines to shorten the timelines of the defence procurement process along with preliminary approvals for procurement ...
ENDPOINTS NEWS17d
Akero ex­ec calls FDA's ac­cel­er­at­ed ap­proval guid­ance for MASH drugs 'bizarre'
NEW YORK — Akero Ther­a­peu­tics may not have ad­e­quate da­ta for ac­cel­er­at­ed ap­proval of its MASH drug, de­spite show­ing it may re­verse cir­rho­sis in pa­tients with … ...