Drug Approval | December 06, 2024
FDA accepts supplemental Biologics License Application for Roche’s Columvi combination
For people with relapsed or refractory diffuse large B-cell lymphoma
For people with relapsed or refractory diffuse large B-cell lymphoma
Granules has undertaken a proactive, voluntary and comprehensive remediation plan to address the six form 483 observations raised by the USFDA
Aster DM Healthcare and Quality Care India Limited have signed definitive agreements to merge, subject to regulatory, corporate and shareholders’ approvals
Glenmark's Travoprost Ophthalmic Solution USP, 0.004% is bioequivalent and therapeutically equivalent to the reference listed drug, Travatan Z Ophthalmic Solution USP, 0.004% of Sandoz
In the near term, the company targets a 42% reduction in absolute Scope 1 and 2 emissions and Scope 3 emissions by FY2030
The product will be marketed by Dr. Reddy's
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR
WINREVAIR met primary endpoint of time to first morbidity or mortality event for the treatment of patients with pulmonary arterial hypertension (PAH) functional class III or IV at high risk of mortality
The Scheme is subject to approval of the secured creditors and shareholders of TML and GTBL
HYMPAVZI’s approval is based on Phase 3 study results demonstrating non-inferiority and superiority compared to routine prophylaxis in eligible patients with hemophilia A or B without inhibitors
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