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
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
ZY19489 is a novel anti-malarial compound active against all current clinical strains of P. falciparum and P. vivax, including drug resistant strains
Applications supported by positive results from the pivotal Phase 3 POETYK-PSO clinical trial program demonstrating superior efficacy of deucravacitinib over Otezla (apremilast)
Obseva announced previously that the company has entered into a partnership with Syneos Health to support commercialization of linzagolix in the US and EU
The BLA is being submitted under the accelerated approval pathway and is primarily based on clinical, biomarker and safety data from the Phase 2b clinical trial in people with early AD and confirmed amyloid pathology
A long waiting period for critical equipment and a 50% hike in the cost of APIs imported from China are among the immediate challenges
It is the first-ever approval in India for the treatment of Female Pattern Hair Loss (FPHL) and will be available only on prescription by a dermatologist
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 software enables real-time communication between patients, caregivers, physicians, and pharmacists and each cartridge in the device has a unique, traceable serial number registered to the patient
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