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News about "US FDA Approval"
US FDA Approves Lirafugratinib for Cholangiocarcinoma
US FDA has approved lirafugratinib for previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma.
US FDA Approval | 25/09/2026 | By News Bureau
Concord Biotech Gujarat Plant Gets One US FDA Observation
Concord Biotech’s formulation facility in Gujarat has completed a US FDA inspection with one minor procedural observation, according to the company.
US FDA Approval | 19/09/2026 | By News Bureau | 101
US FDA OKs First Gene Therapy for Sanfilippo Syndrome A
The US FDA has approved the first gene therapy for pediatric patients with Sanfilippo Syndrome Type A, a rare and progressive neurodevelopmental disease.
US FDA Approval | 19/09/2026 | By News Bureau
Aurobindo Pharma receives US Food and Drug Administration (FDA) final approval for Beclomethasone Dipropionate HFA Inhalation Aerosol, marking its first Metered-Dose Inhaler (MDI) product and expanding its complex respiratory portfolio.
US FDA Approval | 16/09/2026 | By News Bureau
US FDA Approves First Therapy to Target Muscle Loss in Spinal Muscular Atrophy
The US Food and Drug Administration (FDA) has approved Isembyld, the first therapy for Spinal Muscular Atrophy (SMA) that directly targets muscle loss alongside existing treatments.
US FDA Approval | 14/09/2026 | By News Bureau | 103
US FDA Grants Accelerated Approval to Sevabertinib for Advanced NSCLC
The US Food and Drug Administration (FDA) has granted accelerated approval to sevabertinib for locally advanced or metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) with HER2 (ERBB2) TKD activating mutations.
US FDA Approval | 11/09/2026 | By News Bureau
US FDA Approves Treatment for Essential Thrombocythemia
The US Food and Drug Administration (FDA) approves Besremi (ropeginterferon alfa-2b-njft) for adults with essential thrombocythemia, with a recommended starting dose of 250 mcg.
US FDA Approval | 02/09/2026 | By News Bureau
US FDA Approves IMAAVY as First Treatment for Warm Autoimmune Hemolytic Anemia
The US Food and Drug Administration (FDA) has approved IMAAVY (nipocalimab-aahu) as the first treatment for warm autoimmune hemolytic anemia, based on durable hemoglobin responses in phase 2/3.
US FDA Approval | 26/08/2026 | By News Bureau
Lupin Announces Approval from US FDA for Pitolisant Tablets
Lupin receives US Food and Drug Administration (FDA) approval for Pitolisant Tablets, 4.45 mg and 17.8 mg, a generic version of Wakix, for indications covered by the approved labeling.
US FDA Approval | 17/08/2026 | By News Bureau
Lupin Secures US Approval for Sodium Zirconium Cyclosilicate Oral Suspension
Lupin has received US Food and Drug Administration (FDA) approval for Sodium Zirconium Cyclosilicate Oral Suspension, 5 g and 10 g, bioequivalent to AstraZeneca’s Lokelma.
US FDA Approval | 11/08/2026 | By News Bureau
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