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Results For "USFDA"

1159 News Found

Nureca’s manufacturing subsidiary secures USFDA registration
News | April 14, 2025

Nureca’s manufacturing subsidiary secures USFDA registration

This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States


Aurolife Pharma gets 11 observations from USFDA for Raleigh plant
Drug Approval | April 14, 2025

Aurolife Pharma gets 11 observations from USFDA for Raleigh plant

The company does not expect this development to have any material impact on the current business operations


Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension
Drug Approval | April 12, 2025

Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension

Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas


Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab
Drug Approval | April 11, 2025

Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab

Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis


SPARC announces submission of IND Application for SBO-154 to USFDA
News | April 04, 2025

SPARC announces submission of IND Application for SBO-154 to USFDA

The IND application supports the next phase of development of SBO-154


Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial
Drug Approval | April 03, 2025

Alembic announces USFDA final approval for Pantoprazole Sodium for Injection, 40 mg/vial

Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) have an estimated market size of US$ 48 million for twelve months ending December 2024 according to IQVIA


OneSource Specialty Pharma updates on cGMP inspection by USFDA
Drug Approval | April 01, 2025

OneSource Specialty Pharma updates on cGMP inspection by USFDA

The inspection has concluded with four observations


SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
Drug Approval | March 22, 2025

SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility

The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483


USFDA grants Priority Review for new indication of finerenone for patients with common heart failure
Drug Approval | March 20, 2025

USFDA grants Priority Review for new indication of finerenone for patients with common heart failure

Finerenone is the first drug targeting the mineralocorticoid receptor (MR) pathway to demonstrate cardiovascular benefits in a Phase III study in patients with heart failure


Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg
Drug Approval | March 19, 2025

Zydus receives final approval from USFDA for Apalutamide Tablets, 60 mg

Apalutamide is an androgen receptor inhibitor indicated for the treatment of patients with metastatic castration-sensitive prostate cancer