Drug Approval | March 24, 2022
Lupin receives approval from USFDA for Sildenafil for Oral Suspension
The product will be manufactured at Lupin’s facility in Goa, India
The product will be manufactured at Lupin’s facility in Goa, India
USFDA also approved complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesions
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
Data to establish the safety profile and human dose of vaccine candidate
The approval is based on new data from cohorts D and K of the KEYNOTE-158 trial
Nasonex is a registered trademark of Organon and is used by Perrigo and its affiliates under license
In a Nature Communications Medicine publication, the Verita proprietary platform detected 96 per cent of stage 1 pancreatic cancers and three-quarters of stage 1 ovarian cancers using isolated exosomes and AI-enabled protein marker analysis
Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab
First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD) in patients two years of age and older
First approved in 2019, Rinvoq is a JAK inhibitor approved for four indications across gastroenterology, dermatology and rheumatology
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