Zydus receives FDA’s tentative approval for Dapagliflozin Tablets

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases

NATCO receives FDA's tentative approval for Erdafitinib tablets

NATCO’s Erdafitinib is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma harbouring susceptible FGFR3 genetic alteration

Zydus receives final approval from USFDA for Eltrombopag Tablets

Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad

Alembic announces USFDA tentative approval for Bosutinib tablets

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections

Granules Pharmaceuticals secures FDA tentative approval and 180-day exclusivity for Generic Dyanavel XR

This product has only one approved generic and one authorized generic with an addressable market share of US$ 172 million

WORK Medical scores regulatory approval for AI-powered blood analyzer

It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension