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News about "US FDA Approval"
Zydus Lifesciences Secures US FDA Approval for Leuprolide Acetate Injection
Zydus Lifesciences has received final approval from the US Food and Drug Administration (FDA) for its generic version of Leuprolide Acetate injection, in a 14 mg/2.8 mL (1 mg/0.2 mL) multiple-dose vial format.
US FDA Approval | 17/11/2025 | By Darshana | 114
Granules Life Sciences Secures First US FDA Approval for Metformin HCl Tablets
Granules Life Sciences Private Limited, a wholly owned subsidiary of Granules India Limited, has obtained its first approval from the US Food and Drug Administration (US FDA) for Metformin HCl tablets.
US FDA Approval | 12/11/2025 | By Darshana | 128
Jascayd is the first and only preferential inhibitor of phosphodiesterase 4B (PDE4B) to be approved in this indication. This represents a novel mechanism of action that exerts both antifibrotic and immunomodulatory effects, thereby slowing the decline in lung function in IPF patients.
US FDA Approval | 10/10/2025 | By Dineshwori | 279
Lupin Receives Approval from US FDA for Rivaroxaban for Oral Suspension
Lupin’s Rivaroxaban will be manufactured at the company’s Chhatrapati Sambhajinagar facility.
US FDA Approval | 01/10/2025 | By Dineshwori | 182
Amber Implants Secures FDA 510(k) Clearance for VCFix Spinal System
The VCFix Spinal System, a novel treatment for vertebral compression fractures, has received FDA clearance following one-year trial results that confirmed its safety, performance, and significant clinical benefits. A US commercial pilot launch is planned for early 2026, with broader physician availability expected by summer 2026.
US FDA Approval | 19/09/2025 | By Dineshwori | 140
Celltrion Secures US FDA Approval for Expanded Indication for AVTOZMA
Celltrion has received FDA approval for an expanded indication of AVTOZMA IV (tocilizumab-anoh) to treat cytokine release syndrome (CRS), achieving full indication parity with reference biologic ACTEMRA IV in the US.
US FDA Approval | 07/08/2025 | By Mrinmoy Dey | 109
Biocon Biologics Secures FDA Approval for Kirsty
Biocon Biologics has announced that it has received FDA approval for KIRSTY (Insulin Aspart-xjhz), making it the first and only interchangeable biosimilar to NovoLog in the US, marking a major milestone in expanding affordable insulin options.
US FDA Approval | 16/07/2025 | By Mrinmoy Dey | 237
Shilpa Medicare's plant in Telangana bags US FDA clearance
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited (Parent Organization) and its agreed parties
US FDA Approval | 23/09/2022 | By Sudeep Soparkar | 1049
Palette Life Sciences bags US FDA approval for Barrigel rectal spacer
The spacer protects prostate cancer patients during radiation therapy
US FDA Approval | 13/06/2022 | By Sudeep Soparkar | 1003
US FDA approval for Incyte's Olumiant
Eli Lilly and Company and Incyte announced the US Food and Drug Administration (FDA) has approved Olumiant (baricitinib) for the treatment of Covid-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) with a recommended dose of 4-mg once daily for 14 days.
US FDA Approval | 12/05/2022 | By Sudeep Soparkar | 787
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