Shots: The approval is based on P-III CELESTIAL trial result assessing Cabometyx (60 mg qd) vs PBO in 760 patients in ratio (2:1) with advanced HCC receiving 2L treatment & […]readmore
Tags : receives
Shots: CHMP recommendation is based on the results of P-III CheckMate-214 study assessing Opdivo 3 mg/kg (q3w @four doses, q2w) + Yervoy 1 mg/kg vs sunitinib (50 mg qd @four […]readmore
Shots: The FDA’s BT designation is based on P-III ECHELON-2 study results assessing Adcetris + CHP vs CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in 450 patients with CD30+ T-cell lymphoma across […]readmore
Biotech
GSK’s Trelegy Ellipta (Fluticasone Furoate/Umeclidinium/Vilanterol ‘FF/UMEC/VI’) Receives Expanded Level Approval
Shots: The IMPACT study involves assessing of Trelegy Ellipta (qd,100/62.5/25mcg) vs (ICS/LABA Relvar/Breo Ellipta (FF/VI)) (100/25mcg) & ((LAMA)/LABA Anoro Ellipta (UMEC/VI)) (62.5/25mcg) in patients with COPD The Expanded label approval […]readmore
Shots: The KEYNOTE-224 study involves assessing of Keytruda (200mg q3w @24mos) in 104 patients with HCC aged ≥65, previously treated or intolerant to sorafenib KEYNOTE-224 study results: ECOG PS 0 […]readmore
Biosimilars
Regulatory
Coherus’ Udenyca (pegfilgrastim-cbqv) Receives the US FDA Approval for Patients
Shots: Post EU Approval, Udenyca has received FDA approval on basis of non-inferiority data including its PK, PD and immunogenicity in 600 healthy patients, receiving myelosuppressive CT having cancer Udenyca […]readmore
Shots: The approval is based on the results of two P-III studies EVOLVE & EXPAND assessing Symkevi + Kalydeco vs PBO in 750 patients with CF having two copies of […]readmore
Shots: The approval is based on the results of P-III MURANO study assessing Venclexta + MabThera (six cycles) vs (bendamustine + MabThera) (BR) (six cycles) in 389 patients in ratio […]readmore
Biosimilars
Regulatory
Sandoz’s Hymiroz (adalimumab-adaz) Receives the US FDA Approval for Treatment
Shots: The approval is based on the non-inferiority data demonstrating its biosimilarity in terms of PK, immunogenicity and safety meeting all 1Eps & results of ADACCESS study confirming its safety […]readmore
Shots: The approval is based on the results of CANVAS (CANagliflozin cardioVascular Assessment Study) Program assessing Invokana vs PBO + SoC in 10,000 adults having or at risk CV disease […]readmore