Shots: The approval is based on P-III CheckMate-214 study results assessing Opdivo (3mg/kg) + low-dose Yervoy(1mg/kg) vs sunitinib (50mg, qd) in patients with previously untreated advance RCC P-III Checkmate-214 study […]readmore
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Shots: iCertainty is a novel medical imaging device with real-time blood flow in depth of 4-5 mm requiring no injections, dyes, radiation as performed by other medical devices i.e. X-ray […]readmore
Shots: The ODD designation is based on the study results assessing devimistat + high dose cytarabine & mitoxantrone and devimistat + folfirinox in patients with r/r AML and mPC […]readmore
Shots: The approval is based on clinical trials assessing Embrace in 141 patients including 80 pediatric with epilepsy aged 6 to 21 years (generalized tonic-clonic seizures) after winning clearance for […]readmore
Shots: The P-III HERCULES study involves assessing Cablivi vs PBO in 145 patients with acquired thrombotic thrombocytopenic purpura (aTTP) in plasma exchange & immunosuppression P-III HERCULES study results: achievement in […]readmore
Shots: The approval is based on P-III ESAX-HTN study assessing esaxerenone vs eplerenone for 12wks. in patients with essential hypertension, 1EP as SBP / DBP In 2006, Exelixis and Daiichi […]readmore
Shots: The approval from Japanese Ministry of Health is based on two P-III study FRAME & BRIDGE assessing Evenity (210mg) vs PBO in 7,180 & 245 postmenopausal women with osteoporosis & […]readmore
Regulatory
Novartis’s SEG101(crizanlizumab) Receives FDA’s Breakthrough Therapy(BT) Designation for Sickle Cell
Shots: The BTD is based on P-II SUSTAIN study results assessing crizanlizumab (5 mg/kg) vs PBO in patients with/without hydroxyurea therapy for preventing vaso-occlusive crises(VOCs) in SCD P-II SUSTAIN study […]readmore
Shots: • Out of 5 approvals three are for NSCLC patients, one for Melanoma and one for Microsatellite Instability-High (MSI-H) solid tumor patients • Keytruda got approved as monotherapy in […]readmore
Shots: The expansion approval is based on the CA180-372 (NCT01460160) P-II study results assessing Sprycel (qd, 60 mg/m @24 mos.) + CT in 78 patients with Ph+ ALLaged 2 to […]readmore