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News about "US FDA Approval"
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
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
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 | 846
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 | 877
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 | 696
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 | 996
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