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1722 News Found

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria
Biotech | December 16, 2021

USFDA grants Orphan Drug Designation to Zydus’ novel compound to treat malaria

ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains


Lupin’s Goa plant receives EIR from US FDA
News | December 14, 2021

Lupin’s Goa plant receives EIR from US FDA

FDA changes inspection classification of the facility to Voluntary Action Indicated


Zydus receives  USFDA  approval for Phase2(b)/3 trial of Saroglitazar
Biotech | December 10, 2021

Zydus receives USFDA approval for Phase2(b)/3 trial of Saroglitazar

Saroglitazar Mg is an investigational compound in the USA, and is yet to be approved by the U.S. Food & Drug Administration (USFDA) or European Medicines Agency (EMA)


Alembic receives tentative USFDA approval for Selexipag tablets
Drug Approval | December 09, 2021

Alembic receives tentative USFDA approval for Selexipag tablets

The tablets are indicated for the treatment of pulmonary arterial hypertension


USFDA authorises Astra’s antibody cocktail to prevent Covid
Drug Approval | December 09, 2021

USFDA authorises Astra’s antibody cocktail to prevent Covid

Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US to prevent Covid-19


Philips receives FDA 510(k) clearance for acute patient monitors
Digitisation | December 09, 2021

Philips receives FDA 510(k) clearance for acute patient monitors

Philips Patient Monitors IntelliVue MX750 and IntelliVue MX850 pair with advanced software and services to offer clinical decision support, continuous, scalable patient management and enhanced infection control


Healthium Medtech Sri City facility in AP gets U.S. FDA registration
News | December 08, 2021

Healthium Medtech Sri City facility in AP gets U.S. FDA registration

This is the fourth facility from the company to receive this registration


Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue
Biotech | December 07, 2021

Gan & Lee gets U.S. FDA clearance for novel glucagon-like peptide-1 analogue

The investigational compound, GZR18, is a novel analogue of glucagon-like peptide-1 (GLP-1), an incretin hormone responsible for many glucoregulatory effects


Morpen gets U.S. FDA approval for Fexofinadine
Drug Approval | December 05, 2021

Morpen gets U.S. FDA approval for Fexofinadine

Fexofinadine is the most widely used, second-generation antihistamine drug for the treatment of allergy symptoms and hay fever


U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib
Biotech | November 30, 2021

U.S. FDA accepts Bristol Myers Squibb’s application for Deucravacitinib

Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)