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.
Lynparza is the first and only approved PARPi targeting BRCA-mutated HER2-negative high-risk early breast cancer
The drug is expected to cater to the fast growing Rheumatoid Arthritis, Plaque Psoriasis, JIA, Psoriatic Arthritis, Ankylosing Spondylitis, Ulcerative Colitis, Crohns disease, HS and Uveitis markets
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Naproxen Sodium Capsules, 220 mg, of Bionpharma
The product will be manufactured at Lupin's facility in Goa, India.
OrderPoint was designed as an advanced DTR solution from its first release in 2016.
The decision follows authorization from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in May 2022.
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 decision is based on the outcome of a prespecified interim analysis of the Phase 3 AMEERA-5 trial
The study concluded that elevated levels of two proteins help predict how a person will recover from a traumatic brain injury (TBI), providing important information to determine appropriate care
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