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Results For "USFDA-approval"

201 News Found

Reliance Life Sciences appoints Siva Sankar Mahamkali as VP Biosimilars Manufacturing Operations
People | May 22, 2026

Reliance Life Sciences appoints Siva Sankar Mahamkali as VP Biosimilars Manufacturing Operations

Biologics manufacturing veteran brings over two decades of expertise in biosimilars, GMP operations, and large-scale biopharmaceutical manufacturing


Shaily gets regulatory nod for launch of ShailyPen Neo device technology
Medical Device | May 20, 2026

Shaily gets regulatory nod for launch of ShailyPen Neo device technology

The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval


Roche Pharma launches India’s first subcutaneous immunotherapy for lung cancer
Biopharma | May 19, 2026

Roche Pharma launches India’s first subcutaneous immunotherapy for lung cancer

Tecentriq SC reduces treatment administration time by nearly 80 percent and has the potential to lower indirect treatment costs


Alembic Pharma receives USFDA tentative approval for Darolutamide tablets
Drug Approval | May 15, 2026

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States


NIFTY Pharma remains resilient amid mixed market sentiment
News | May 05, 2026

NIFTY Pharma remains resilient amid mixed market sentiment

Pharma and healthcare stocks stay in focus as investors track earnings, USFDA approvals, hospital growth, and global market pressures


Caplin Steriles gets FDA approval for desmopressin
Drug Approval | March 02, 2026

Caplin Steriles gets FDA approval for desmopressin

Desmopressin Acetate Injection is primarily used to treat central diabetes insipidus, haemophilia A, and von Willebrand disease


Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease
Drug Approval | February 07, 2026

Zydus receives USFDA ODD for Desidustat for the treatment of sickle cell disease

This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease


Elanco scores USDA nod for new canine allergy drug Befrena
News | January 04, 2026

Elanco scores USDA nod for new canine allergy drug Befrena

Elanco expects Befrena to launch in the US in the first half of 2026


Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia
Drug Approval | November 06, 2025

Zydus receives FDA’s ODD for Desidustat for the treatment of beta-thalassemia

Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval


Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr
News | August 08, 2025

Biocon Q1 FY26 PAT slips 95% to Rs. 31.4 Cr

Revenue from operations rose 14.8 per cent year-on-year to Rs. 3,942 crore