Shots: The approval is based on data from 2 pivotal studies i.e OSPREY & CONDOR evaluating the safety & diagnostic performance of Pylarify in patients with prostate cancer Results: 1st […]readmore
Tags : approval
Shots: The approval is based on efficacy and safety data from the P-III LIBERTY 1 & 2 studies assessing Myfembree (relugolix 40 mg, estradiol 1 mg & norethindrone acetate 0.5 […]readmore
Shots: The approval is based on P-III VIALE-A and P-Ib M14-358 studies. The P-III study involves assessing Venclyxto + azacitidine in patients with newly diagnosed AML who were ineligible for […]readmore
Shots: The NDA submission is based on P-I study of adult patients, the P-II NAVIGATE trial in adult and adolescent patients and the P- I/II pediatric SCOUT trial. These trials […]readmore
Shots: The CHMP recommended the approval of Libtayo as a 1L treatment for adults with NSCLC expressing PD-L1 in ≥50% of tumor cells with no EGFR, ALK or ROS1 aberrations, […]readmore
Shots: The US FDA has granted accelerated approval which is based on P-I CHRYSALIS study assessing Rybrevant as a monothx. in patients metastatic non-small cell lung cancer with epidermal growth […]readmore
Shots: The opinion is based on P-II CheckMate -142 study assessing Opdivo + Yervoy in patients with mismatch repair deficient or microsatellite instability–high metastatic colorectal cancer whose disease had progressed […]readmore
Shots: MHLW has granted EUA for Vaxzevria (ChAdOx1-S [Recombinant]) for active immunization of individuals aged ≥18yrs. to prevent COVID-19. The EUA is based on P-III data from the Oxford University-led […]readmore
Shots: MHLW has granted special approval under article 14-3 of the PMDA for emergency use of Moderna’s mRNA COVID-19 vaccine based on Takeda’s P-I/II immunogenicity and safety clinical trial The […]readmore
Shots: The approval is based on P-III head-to-head PEGASUS study assessing Empaveli vs Soliris (eculizumab) in 80 adults with PNH. Participants should be Soliris stable for at least 3mos. with […]readmore