Lupin wins FDA nod for generic colonoscopy prep drug with first-to-file exclusivity
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
Crucially, Lupin is the exclusive first-to-file applicant for this product and is eligible for 180-day generic drug exclusivity in the U.S. market
The programme evaluated anselamimab as a first-line add-on to standard plasma cell dyscrasia therapy in patients with advanced cardiac AL amyloidosis
The study tracked patients for more than five years (median 60.7 months), with protection against disease returning emerging in under four months and continuing long term
The approved product is the generic equivalent of Sutab® Tablets developed by Azurity Pharmaceuticals
Libre Duo devices become the first glucose-ketone monitors approved for diabetes care, offering real-time alerts for diabetic ketoacidosis risk
The move marks one of the most significant coverage expansions yet in obesity care, bringing FDA-approved treatment options further into mainstream insurance plans rather than out-of-pocket reach
BPDCN typically presents with skin lesions before rapidly spreading to the bone marrow, lymph nodes
The decision clears the drug as a monotherapy for adults with unresectable, locally advanced or metastatic non-small cell lung cancer
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
A one-shot gene-editing cholesterol therapy could soon be a reality
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