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Results For "U.S"

1563 News Found

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%
Drug Approval | March 21, 2025

Glenmark receives ANDA approval for Olopatadine Hydrochloride ophthalmic solution USP, 0.2%

Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% (OTC), will be distributed in the US by Glenmark Therapeutics, USA.


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


Lupin receives tentative approval from USFDA for Amifampridine Tablets
Drug Approval | March 18, 2025

Lupin receives tentative approval from USFDA for Amifampridine Tablets

Amifampridine Tablets, 10 mg are indicated for the treatment of Lambert-Eaton myasthenic syndrome in adults and pediatric patients 6 years of age and older.


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


Zynext Ventures invests in Illexcor Therapeutics to advance novel oral therapy for sickle cell disease
News | March 13, 2025

Zynext Ventures invests in Illexcor Therapeutics to advance novel oral therapy for sickle cell disease

Illexcor is developing a first-in-class oral drug that directly targets the root cause of SCD


Sun Pharma to acquire Nasdaq-listed Checkpoint Therapeutics
News | March 10, 2025

Sun Pharma to acquire Nasdaq-listed Checkpoint Therapeutics

Will add UNLOXCYT (cosibelimab-ipdl), the first and only FDA-approved anti-PD-L1 treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) to Sun Pharma's global onco-derm franchise


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