Drug Approval | December 21, 2021
CDSCO increases shelf life of Covaxin
The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO
The approval of shelf life extension is based on the availability of additional stability data, which was submitted to the CDSCO
Given as few as six times per year and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
Prucalopride medicine in the form of Orally Disintegrating Strips are most convenient dosage form for geriatric patients
It is indicated for the treatment of patients with acromegaly and Gastroenteropancreatic Neuroendocrine Tumours
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research
Syngene will also build and operate a new dedicated drug development laboratory to accelerate the advancement of Amgen R&D projects
It is the first approved generic and is eligible for 180 days of Competitive Generic Therapy exclusivity
Orencia is the first FDA-approved therapy to prevent acute graft versus host disease following hematopoietic stem cell transplant
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