Tag: Approval
Lupin receives Health Canada approval for biosimilar Pegfilgrastim
This product will be marketed under the brand name Armlupeg® and manufactured at Lupin’s Biotech facility at Pune, India
Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Orchid Pharma’s PAT surges by 71.60% in Q4
Innovative drug Enmetazobactam gains EMA & USFDA approval, Orchid Pharma expands presence in the antibiotics market
Biocon Biologics obtains US-FDA approval for biosimilar Aflibercept for Yesafili
A significant milestone for the company marking its entry into ophthalmology, a new therapeutic area in the United States
Biocon Biologics announces positive CHMP opinion for its biosimilar to treat...
The CHMP positive opinion will be considered by the European Commission whose decision on the approval is expected by the end of September 2023
Eyestem seeks IND approval for its product to treat geographic atrophy
The disease is largest cause of incurable blindness in the world for people over 50
Marut Drones wins bronze at Telangana State Industry Awards 2022 as...
Marut Drones was also accorded RPTO approvals enabling training and capacity building of drone pilots for safe agriculture operations, repair and maintenance
Concept Medical receives US-FDA’s IDE approval for its Magic Touch PTA
In BTK indication for its Sirolimus Coated Balloon Magic Touch PTA
Lupin & DKSH sign an exclusive licensing & supply agreement to...
According to the agreement, Lupin’s subsidiary in Philippines, Multicare Pharmaceuticals, will file for marketing approval and be responsible for distribution and commercialization of the biosimilars once approved
Sanofi & GSK to seek USFDA & EMA approval for Covid-19...
When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units