Drug Approval | August 22, 2022
USFDA grants emergency use authorization for Novavax COVID-19 vaccine
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
~96% decline reported in Malaria cases in Madhya Pradesh, due to public-private-people partnership
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines
Genentech will be granted an exclusive license to develop and commercialize the degrader worldwide, and will be fully responsible for the development and commercialization costs.
GlobalData’s ‘Pharmaceutical Intelligence Center’ observes that India is still in the nascent stage of developing these potential therapies as currently only four cell/gene therapy molecules are being developed in the country.
The integrated services ensure that NextPoint can bring their molecule to the clinic in a timely manner.
The decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
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