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News about "US FDA Approval"
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 | 172
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 | 128
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 | 102
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 | 101
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 | 169
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 | 922
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 | 977
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 | 755
Generic Pradaxa Capsules from Alembic Pharma given tentative approval by the US FDA
Alembic Pharmaceuticals Limited has gotten speculative endorsement from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for dabigatran etexilate cases, 75 mg, 110 mg, and 150 mg.
US FDA Approval | 08/04/2022 | By Sudeep Soparkar | 1062
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