Drug Approval | August 30, 2024
Natco Pharma announces submission of TABRECTA to USFDA
TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA
TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA
First-in-human Phase-1 study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SUVN-I6107 in healthy subjects
First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations
Brimonidine Tartrate Ophthalmic Solution, 0.1% is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
Also received tentative approval for 137 mg
Launches Opentop 40, Opentop D, Opentop L, Opentop Dsr and Cefix 200 which are available for sale
Ordspono is Regeneron’s first approved bispecific antibody and will provide an off-the-shelf option that can be administered in the out-patient setting, with hope for complete remission
Winrevair is the first activin signaling inhibitor therapy for PAH approved in Europe
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
The grant is designated for the research and development of Pyronaridine
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