Tags : Approves

MedTech Regulatory

The US FDA Approves Patient Specific Talus Spacer to Treat

Shots: The FDA has approved Patient-Specific Talus Spacer 3D-printed talus implant for humanitarian use. The FDA reviewed data through the HDE process Data supporting the safety of implant include results from 31 patients and 32 talus replacement surgeries with the implant. Post-operation @3yrs, pain decreased from “mod. to sev.” prior to surgery to “mild” post-surgery, […]Read More


The US FDA Approves Gallium 68 PSMA-11 as the First

Shots: The approval is based on two prospective studies assessing Ga 68 PSMA-11 in 960 men with prostate cancer. The first trial enrolled 325 patients & the second trial enrolled 635 patients with biopsy-proven prostate cancer who underwent PET/CT or PET/MRI scans and who had rising serum PSA levels after initial prostate surgery or radiotherapy […]Read More

Pharma Regulatory

MHLW Approves Novartis’ Five New Therapies Expanding its Footprints in

Shots: The five therapies include Tabrecta (capmatinib) for advanced and recurrent unresectable NSCLC, Entresto (sacubitril valsartan sodium hydrate) for chronic HF, Mayzent (siponimod fumaric acid) for secondary PMS, Enerzair (glycopyrronium bromide, indacaterol acetate, mometasone furoate) and Atectura (indacaterol acetate, mometasone furoate) for different forms of asthma In 2020, Novartis has received seven approval in Japan […]Read More


The European Commission Approves the Merger of Mylan and Upjohn

Shots: The EC has approved the Viatris merger (a merger b/w Upjohn and Mylan) under EU merger regulations but the decision is conditional on the divestment of Mylan’s certain generic therapies EC ensures that the merger does not harm competition and preserves the competitive access to certain genericized therapies for national health services and the […]Read More


FDA Approves Elzonris (tagraxofusp), the First Treatment for Blastic Plasmacytoid

Shots: The approval is based on the STML-401-0114 (NCT 02113982) study assessing immunophenotypic diagnostic CD123, CD4 & CD56 patients in treatment-naïve and previously-treated patients IV STML-401-0114 results: Elzonris(12 mcg/kg/day): ORR 90% (26/29); CR/CRc 72% (21/29); 45% of patients went for SCT post Elzonris treatment Elzonris is a CD123-targeted therapy indicate to treat adult and pediatric patients with […]Read More


Congo Approves Experimental Ebola Treatments by Gilead, Mapp, Toyama Chemical

Shots: Congo approves experimental Ebola treatments including Remdesivir by Gilead Sciences; ZMapp by Mapp Pharmaceutical; Favipiravir by Toyama and Regn3450, Regn3471, Regn3479 by Regeneron Pharmaceuticals Health authorities has approved these experimental treatments, as the Ebola epidemic continues to spread   Total number of death are 59 and confirmed cases to 75 since last month, with […]Read More