Summary:- TZIELD is the first disease-modifying therapy in T1D, a life-threatening autoimmune disease In a clinical trial, in Stage 2 T1D patients,…
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U.S FDA
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RegulatoryU.S FDA
Libtayo® (cemiplimab-rwlc) in Combination with Chemotherapy Approved by the FDA as First-line Treatment for Advanced Non-small Cell Lung Cancer (NSCLC)
by adminby adminSummary: Approval based on superior survival outcomes of Libtayo plus chemotherapy, compared to chemotherapy alone, in a patient population with a wide…
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CompaniesPfizerRegulatoryU.S FDA
Pfizer’s Elranatamab Granted FDA Breakthrough Therapy Designation for relapsed or Refractory Multiple Myeloma
by adminby adminPfizer Inc. (NYSE:PFE) announced its investigational cancer immunotherapy, elranatamab, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for…
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RegulatoryU.S FDA
U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
by adminby adminSummary-The Food and Drug Administration granted accelerated approval to teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), the first bispecific B-cell maturation antigen (BCMA)-directed CD3…
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RegulatoryU.S FDA
Nevro Announces FDA Approval of HFX iQ™ Spinal Cord Stimulation System to Personalize the Treatment of Chronic Pain
by adminby adminNext Generation Senza® HFX iQ™ is the First and Only SCS System that Uses Artificial Intelligence to Optimize and Maintain Pain Relief…
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RegulatoryU.S FDA
Santen and UBE Received FDA Approval for OMLONTI® (Omidenepag Isopropyl Ophthalmic Solution) 0.002% for the Reduction of Elevated Intraocular Pressure in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension
by adminby adminSanten Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (Santen), and UBE Corporation (UBE) today announced that the U.S. Food and…
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RegulatoryU.S FDA
bluebird bio Receives FDA Accelerated Approval for SKYSONA®(elivaldogene autotemcel)Gene Therapy for Early, Active Cerebral Adrenoleukodystrophy (CALD)
by adminby adminSynopsis: SKYSONA is the first FDA approved therapy shown to slow the progression of neurologic dysfunction in boys with this devastating and…
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RegulatoryU.S FDA
Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (Terlipressin) for Injection for the Treatment of Hepatorenal Syndrome (HRS)
by adminby adminHighlights: Terlivaz is the first and only FDA-approved treatment for adults with HRS involving rapid reduction in kidney function. Terlivaz is expected…
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RegulatoryU.S FDA
Spectrum Pharmaceuticals Receives FDA Approval for ROLVEDON™ (eflapegrastim-xnst) Injection
by adminby adminSummary: First novel Long-Acting GCSF (LA-GCSF) product approved in over 20 years ROLVEDON™ developed using proprietary LAPSCOVERY™ technology with a differentiated molecular structure and…
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Bristol Myers SquibbRegulatoryU.S FDA
Bristol Myers Squibb Notches another FDA Approval for Sotyktu™ (Deucravacitinib), Oral Treatment for Adults with Moderate-to-Severe Plaque Psoriasis
by adminby adminHighlights: Bristol Myers Squibb’s Sotyktu, a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, is the only approved TYK2 inhibitor worldwide and the…