Drug Approval | December 20, 2025
Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
The trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival
If cleared by regulators, CagriSema would become the first treatment to combine a GLP-1 receptor agonist and a long-acting amylin analogue in a single injection
Patients with BRCA mutations often face aggressive disease and poor prognosis
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
The EMBOLD study evaluated relutrigine for patients with SCN2A and SCN8A developmental and epileptic encephalopathies
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