Drug Approval | September 06, 2021
Accutest enables NMPA approval for Qilu’s Abiraterone
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
The bioequivalence study was conducted by Accutest Research India, one of the preferred CRO players in India
Acne affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago
It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo
The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks
Enoxaparin Sodium Injection, USP is used for prophylaxis of Deep Vein Thrombosis (DVT) in patients undergoing abdominal, hip or knee replacement surgery, and also for the treatment of acute DVT
It is estimated that 300 million men worldwide were affected by ED in 2020, a figure projected to increase to 322 million by 2025. Nearly 30% of these were aged between 40 and 70
The data suggest that a booster dose given within 6 to 12 months after the second dose may help maintain a high level of protection against COVID-19.
This is the first of its kind vaccine for Covid 19 to get the go-ahead
Targeting KIT by frameshifting mRNA transcripts as a therapeutic strategy for aggressive mast cell neoplasm
The approval is based on a multi-centre, single-arm, open-label pivotal clinical trial
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