Aurobindo receives final ANDA approval for Rivaroxaban Tablets USP, 2.5mg
The product will be launched in Q1FY26
The product will be launched in Q1FY26
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
Revolf's infertility and miscarriage tests are a new technology that uses blood tests to detect neoself-antibodies
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
New analyses, including presentations on mavacamten, apixaban and milvexian, further solidify the company's strength and expertise as a leader in cardiovascular diseases
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Dabigatran Etexilate Capsules are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients
The company has received five final approvals
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