Shots: The CHMP approval is based on data demonstrating analytical, preclinical, and clinical information, confirming biosimilar pegfilgrastim as a reference medicine in febrile neutropenia in terms of safety, efficacy and […]readmore
Shots: Hulio’s EU Marketing Approval is followed after CHMP approval that demonstrated analytical, functional, clinical and immunogenicity data similar to AbbVie’s Humira In 2018, Kyowa and Mylan signed an agreement […]readmore
Shots: Hironic’s AFit laser acne device is a combination of 1450nm diode laser, radio frequency (RF), and Cryogen Cooling Device (CCD) into a one device AFit suppresses sebaceous excretion with […]readmore
Shots: Approval of Cabometyx (cabozantinib) is based on results of the P-III METEOR trial assessing Cabometyx vs everolimus for advanced (RCC) previously received vascular endothelial growth factor (VEGF) targeted therapy, […]readmore
Shots: Ilumetri’s (tildrakizumab) approval is based on the positive results from reSURFACE 1 and 2 P-III clinical trial, testing its safety and efficacy in >200 clinical sites worldwide reSURFACE 1 […]readmore
Shots: AJOVY (remanezumab-vfrm) is evaluated in two P-III trial enrolling patients with disabling migraine, administering AJOVY alone and in combination with oral preventive treatments, showing reduction in monthly migraine days […]readmore
Shots: The FDA approval is based on P-I JIGSAW-118 (N=51) study assessing PK/PD with appropriate dosage regimen of Actemra SC (aged <17yrs) with range of BWs (weight <30 kg administering […]readmore
Shots: The approval is based on P-III ‘1053’ trial conducted across 34 sites in 14 countries assessing Lumoxiti (moxetumomab pasudotox-tdfk) in patients with r/r HCL, testing its safety, efficacy, immunogenicity […]readmore
Shots: Approval is based on three clinical trials (N=80) assessing safety, tolerability, PK, haemostatic efficacy of rVWF in adults: P-III for rFVIII with severe VWD; P-III for rFVIII and rVWF […]readmore
Shots: Monoferric is being approved for anaemic adult patients intolerant or unresponsive to iron oral therapy with an expection to reach market by Nov 2018 In 2015, Pharmacosmos signed Canada […]readmore
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