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News about "US FDA Approval"
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
US FDA Approves Takeda's ORZEYFUL for Narcolepsy Type 1
US Food and Drug Administration (FDA) approves Takeda's ORZEYFUL (oveporexton), the first orexin therapy to treat the underlying cause of Narcolepsy Type 1 in adults.
US FDA Approval | 07/08/2026 | By News Bureau
Zydus Wins US FDA Approval for Generic Indocyanine Green Injection
Zydus has received US Food and Drug Administration (FDA) approval for generic Indocyanine Green Injection, expanding its injectable imaging portfolio and functional dyes business.
US FDA Approval | 06/08/2026 | By News Bureau | 111
Nipro Launches FDA-Cleared ELISIO-HX Dialyzer to Expand Hemodialysis Access in the U.S.
Nipro Medical Corporation has commercially launched the FDA-cleared ELISIO-HX dialyzer in the U.S., introducing an expanded hemodialysis solution that enhances middle molecule removal while integrating seamlessly into existing dialysis workflows without requiring new equipment.
US FDA Approval | 06/08/2026 | By News Bureau | 110
US FDA Grants Breakthrough Therapy Designation to Lilly's Olomorasib for Advanced Pancreatic Cancer
The US FDA has granted Breakthrough Therapy designation to Eli Lilly's investigational KRAS G12C inhibitor, olomorasib, for treating previously treated advanced pancreatic cancer, reinforcing its potential across difficult-to-treat KRAS-driven cancers.
US FDA Approval | 04/08/2026 | By News Bureau
Biocon Announces US Commercial Launch of Yesafili, a Biosimilar to Regeneron's Eylea 2 mg
Biocon has launched Yesafili, an interchangeable biosimilar to Eylea 2 mg in the US, expanding access to treatment for Age-related Macular Degeneration (AMD) and other retinal diseases.
US FDA Approval | 03/08/2026 | By News Bureau
Viatris Wins US FDA Approval for Once-Weekly Gwyn Lo Contraceptive Patch
Viatris has received US Food and Drug Administration (FDA) approval for Gwyn Lo, a once-weekly low-dose estrogen contraceptive patch, expanding women's health treatment options.
US FDA Approval | 30/07/2026 | By News Bureau
Cipla Wins US FDA Approval for Generic Advair Diskus
Cipla has received US Food and Drug Administration (FDA) approval for its generic Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in all 3 strengths.
US FDA Approval | 29/07/2026 | By News Bureau
US FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer's Disease
The US Food and Drug Administration (FDA) has approved Leqembi Iqlik (lecanemab-irmb) as a once-weekly subcutaneous starting dose for early Alzheimer's Disease (AD), with a U.S. launch planned for August 2026.
US FDA Approval | 14/07/2026 | By News Bureau
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