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Results For "U.S.-Food-and-Drug-Administration"

594 News Found

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


Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma
News | March 20, 2025

Briefs: Dr. Agarwal's Eye Hospital and Apitoria Pharma

Apitoria Pharma’s API manufacturing facility classified as VAI by USFDA


RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation
Drug Approval | March 19, 2025

RedHill Biopharma to submit FDA-approved Talicia for UK marketing authorisation

Talicia is also approved and launched in the UAE and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes


Dr. Reddy's issues nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL in US
News | March 18, 2025

Dr. Reddy's issues nationwide recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL in US

The product is being recalled because the infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL single-dose bag, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 m


Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis
Clinical Trials | March 08, 2025

Biocon Biologics announces positive results from Phase 3 study of Yesintek biosimilar to Ustekinumab for chronic plaque psoriasis

The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara


Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US
News | March 07, 2025

Biocon Biologics and Civica collaborate to expand Insulin Aspart access in US

There are 38.4 million people with diabetes in the United States


Biocon Biologics launches Yesintek Biosimilar to Stelara in US
News | February 25, 2025

Biocon Biologics launches Yesintek Biosimilar to Stelara in US

YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis


Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business
News | February 22, 2025

Granules India acquires Swiss Senn Chemicals to foray into peptide and CDMO business

The acquisition aligns with Granules' vision to enter the rapidly expanding peptide-based anti-diabetic and anti-obesity market


Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved