Drug Approval | February 19, 2022
US FDA to review Amylyx new drug application for AMX0035
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).
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
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
It will open new frontier for south-to-south collaboration and innovation transfer
On track to complete the BLA submission in the first half of 2022
The vaccine will be priced at Rs. 265 per dose and the applicator being offered at Rs. 93 per dose excluding GST
A National Tele Mental Health Programme is being launched to address mental health issues. We spoke to healthcare industry leaders who shared their outlook
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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