AstraZeneca India gets CDSCO approval for additional indication for Osimertinib in unresectable…
The approval follows evidence from the Phase III LAURA trial, which demonstrated significant clinical benefits in delaying disease…
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Browsing Tag
drug approval
Lupin launches Tolvaptan Tablets in the US
Lupin holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity
Entvin AI raises $500K in Y combinator funding to streamline FDA drug approval process
Entvin AI, founded by IIT Bombay graduates, launches its AI platform to optimise regulatory compliance for pharmaceutical…
Lupin gains tentative USFDA approval for Amifampridine Tablets
Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg of Catalyst Pharmaceuticals
Dr. Reddy’s Secures Exclusive Rights to Commercialize HLX15 in U.S. & Europe
HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection, with intravenous as well as subcutaneous formulations
Gland Pharma secures US FDA approval for Latanoprost Ophthalmic Solution
Product targets treatment of high intraocular pressure in glaucoma and ocular hypertension patients
Lupin gains tentative USFDA nod for Sitagliptin and Metformin Hydrochloride Tablets
Sitagliptin and Metformin Hydrochloride tablets to market a generic equivalent of Janumet tablets of Merck Sharp & Dohme
Dr. Reddy’s launches Toripalimab under the brand name Zytorvi in India
Toripalimab is an immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma
FDA approves Genentech’s Vabysmo Prefilled Syringe (PFS) for three leading causes of vision loss
Vabysmo PFS is reportedly the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal…
Alembic Pharmaceuticals receives five US FDA product approvals in Q1FY25
Receives 3 final and 2 tentative product approvals thus far in Q1FY25