Drug Approval | February 18, 2022
USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022
The supplemental adolescent approval enhances Solosec’s strong position as the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV
Rimegepant is the first oral calcitonin gene-related peptide receptor antagonist to demonstrate positive results in a pivotal trial in the Asia Pacific
On track to complete the BLA submission in the first half of 2022
Key takeaways of recent quarter & conference call highlights
Caplin Point Laboratories has reported consolidated financial results for the period ended December 31, 2021.
The vaccine will be priced at Rs. 265 per dose and the applicator being offered at Rs. 93 per dose excluding GST
The award was given as a result of NASSCOM's meticulous screening process, in which over 700 start-ups were shortlisted as the most promising companies of the year
APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types
Pfizer is evaluating the FDA’s comments and will work with the agency to determine an appropriate path forward
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