Drug Approval | June 01, 2024
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
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes
Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment.
The U.S. FDA has determined that the inspection classification of the facility is Voluntary Action Indicated
The product will be manufactured at Lupin's facility in Goa, India.
Meclizine Hydrochloride Tablets had estimated annual sales of USD 29 million in the U.S.
The product will be manufactured at Lupin's facility in Nagpur, India.
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
The objective of this Phase 1 study is to determine the safety and tolerability of OLX10212 in patients with advanced AMD at multiple sites in the US.
Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk
It is the first monoclonal antibody drug for use in any animal species
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