Moderna’s new Covid vaccine mNEXSPIKE wins European approval

mNEXSPIKE is the third Moderna vaccine authorized in the European Union, strengthening the Company's respiratory vaccine portfolio in Europe

Roche appoints Mark Dawson as new Head of Pharma Research and Early Development

Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research

NATCO receives CDSCO approval for Semaglutide in India

Semaglutide is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus

Zydus receives final approval from USFDA for Ammonium Lactate Cream, 12%

FDA refuses to file Moderna’s seasonal flu vaccine application, citing comparator issue

The FDA’s Center for Biologics Evaluation and Research (CBER) cited Moderna’s choice of a licensed standard-dose flu vaccine as the comparator in its Phase 3 trial, saying it “does not reflect the best-available standard of care.”

£1bn London Cancer Hub expansion wins planning approval

The approved scheme will deliver around 1 million sq ft of state-of-the-art laboratory and research space across a 12-acre site

GSK’s Nucala receives European Commission approval to treat chronic obstructive pulmonary disease

Nucala is the first and only monthly biologic in the EU evaluated in a wide COPD population with an eosinophilic phenotype

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