Lupin receives tentative USFDA approval for Rivaroxaban Tablets USP

Sagimet Biosciences announces positive topline results from phase 2b trial of denifanstat

Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023

European Commission grants ODD to NS-229 for treatment of Eosinophilic Granulomatosis

The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union

Granules India posts Q3 FY24 consolidated PAT at Rs. 125.65 Cr

Granules India has reported total income of Rs. 1156.23 crores during the period ended December 31, 2023

AstraZeneca Pharma India receives permission to import new drug

The receipt of this permission paves way for the launch of Andexanet alfa powder for solution for infusion 200 mg (Andexxa) in India

Novo Holdings expands portfolio in cancer diagnostics

Growth team leads financing round in Cleveland Diagnostics; company to advance novel blood-based diagnostic technology to improve and lower costs for patients with cancer

Thermo Fisher receives AIFA’s GMP approval for manufacturing facility of RNA-based products in Italy

GMP certification helps enable biotechnology customers to accelerate accessibility of new RNA-based therapies for patients

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets