Shots: The approval is based on the CANVAS program i.e. CANVAS & CANVAS-R study assessing Invokana vs PBO in 10,142 adults with T2D who have or are at risk of […]readmore
Shots: The US FDA’s ODD may enable Axsome a seven years of marketing exclusivity in the US, with incentives and reduction in user fees of product required for PDUFA act […]readmore
Shots: The Fourth ODD is based on the ongoing P-III POLO study assessing Lynparza (300mg bid) as monotherapy vs PBO in ratio (3:2) & 1EP as PFS in 145 patients […]readmore
Shots: Konan acquired objectiveFIELD Device from Australian National University (ANU) including 15 issued patents in 9 countries, 6 patients in the process, and clinical data for multiple diagnostic indications and […]readmore
Shots: The approval is based on EMBRACA trial results assessing Talzenna (1mg) vs CT in 431 patients with BRCA-mutated HER2-negative locally advanced or metastatic breast cancer for a duration of […]readmore
Shots: The approval is based on P-II BRIGHT (1003) trial study results assessing Daurismo + cytarabine (LDAC) & daunorubicin vs PBO + cytarabine & daunorubicin in 115 patients in ratio […]readmore
Shots: The approval is based on a study assessing Gardasil 9 in 13,000 patients (age 27- 45 yrs) for the prevention of certain cancers and diseases caused by the nine […]readmore
Shots: The approval is based on two P-III studies assessing Orilissa 150 mg qd and 200 mg bid vs PBO enrolling 1,700 women with moderate to severe endometriosis pain P-III […]readmore
Shots: The Notice of Compliance (NOC) authorization is based on the clinical trial assessing Radicava (edaravone), demonstrating its positive 1EP measured by using the ALSFRS-R Edaravone is a IV medication, […]readmore
Shots: The approval is based on two study results assessing Revcovi in patients and demonstrated in an increase in ADA activity, reduction in concentration of toxic metabolites with an improvement […]readmore
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