Paris-based Ipsen secured Fast Track designation from the U.S. Food and Drug Administration for Onivyde (irinotecan liposome injection) for study patients with small cell lung cancer (SCLC) who progressed following a first-line platinum-based regimen.
While the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.
Aptinyx Jumps Following Positive Phase II PTSD Study Results Published: Oct. 20, 2020 By Alex Keown BioSpace Shares of Aptinyx skyrocketed more than 75% after the company reported its mid-stage experimental treatment for post-traumatic stress disorder demonstrated clinically meaningful and statistically significant results that will set up a pivotal study next year. This morning, […]
Galapagos and Servier reported that their ROCELLA Phase II clinical trial of GLPG1972/S201086 failed to meet the study’s primary endpoint in osteoarthritis knee repair.
Pfizer snagged Fast Track designation from the U.S. Food and Drug Administration for the company’s Duchenne muscular dystrophy (DMD) gene therapy treatment, PF-06939926.
ALX Oncology is partnering with pharma giant Merck to evaluate a combination of the CD47 inhibitor ALX148 with the blockbuster Keytruda as a potential treatment for patients with head and neck squamous cell carcinoma (HNSCC).
The U.S. Food and Drug Administration accepted Copenhagen, Denmark-based Orphazyme’s New Drug Application (NDA) for arimoclomol for the treatment of Niemann-Pick disease Type C.
August is a busy month on the U.S. Food and Drug Administration)’s calendar, including a target action date for Bristol Myers Squibb’s supplemental Biologics License Application for Opdivo (nivolumab) plus Yervoy (ipilimumab), dosed concomitantly with a limited course of chemotherapy, for the first-line treatment of metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Pfizer Inc. and partner BioNTech SE said two of their experimental coronavirus vaccines received ‘fast track’ designation from the U.S. health agency, speeding up the regulatory review process.