Lupin receives warning letter from US FDA

The company does not believe that the warning letter will have an impact on disruption of supplies or the existing revenues from operations of this facility

Lupin launches Sildenafil for Oral Suspension in US

Sildenafil for Oral Suspension (RLD Revatio) had estimated annual sales of US $64 million in the US

Pfizer and BioNTech submit application to USFDA for emergency use authorization of Omicron BA.4/BA.5-adapted bivalent vaccine booster for 5-11 year age

The companies have also initiated a Phase 1/2/3 study NCT05543616 to evaluate the safety, tolerability, and immunogenicity of different doses

U.S. District Court rules in favor of Merck in Sitagliptin Phosphate patent lawsuit

Sitagliptin is an active ingredient in JANUVIA, JANUMET and JANUMET XR

Cipla receives EIR for Indore plant, Aurbindo for Raleigh

The plant at Raleigh, North Carolina, USA owned by Aurolife Pharma has received an establishment inspection report (EIR)

BridgeBio Pharma, Sentynl Therapeutics receive marketing authorization in the EU for fosdenopterin

NULIBRY is a first-in-class cPMP substrate replacement therapy to reduce the risk of mortality in patients with MoCD Type A.

Shilpa Medicare receives tentative approval for Tenofovir Alafenamide Tablets

The ANDA was filed as 'First to File' submission on NCE-1 date.

Merck to initiate new Phase 3 clinical program for treatment of HIV-1 Infection

Phase 2 study evaluating an investigational weekly oral combination treatment regimen of islatravir and Gilead Sciences’ lenacapavir to resume with lower dose of islatravir

DME market across 7MM set to reach $11.1 billion in 2031, forecasts GlobalData

Zydus receives tentative approval from USFDA for Sugammadex Injection

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery