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RSS FeedPosted by Michael Wonder on 27 Apr 2022
Editas Medicine receives FDA rare paediatric disease designation for EDIT-301 for the treatment of beta thalassaemia
26 April 2022 - Editas Medicine today announced that the U.S. FDA granted rare paediatric disease designation to EDIT-301, an investigational, ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and BioNTech submit application for U.S. emergency use authorisation for a COVID-19 vaccine booster dose in children 5 through 11 years of age
26 April 2022 - Pfizer and BioNTech today submitted an application to the U.S. Food and Drug Administration (FDA) for ...
Posted by Michael Wonder on 27 Apr 2022
Enhertu granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer
27 April 2022 - Based on DESTINY-Breast04 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a significant improvement in both progression-free ...
Posted by Michael Wonder on 26 Apr 2022
Prothena receives FDA fast track designation for PRX012, a next generation anti-amyloid beta antibody under investigation for the treatment of Alzheimer’s disease
26 April 2022 - PRX012 is a potential best in class, subcutaneous anti-amyloid beta antibody therapy currently in a Phase ...
Posted by Michael Wonder on 26 Apr 2022
Intra-Cellular Therapies announces FDA approval of new dosage strengths for Caplyta (lumateperone) for specific patient populations
25 April 2022 - Caplyta label now includes dosage recommendations for specific patient populations; those with moderate or severe hepatic ...
Posted by Michael Wonder on 26 Apr 2022
VBL Therapeutics receives FDA fast track designation for ofra-vec for the treatment of platinum-resistant ovarian cancer
26 April 2022 - OVAL Phase 3 top-line progression-free survival primary outcome data for ofra-vec expected in 2H 2022; with ...
Posted by Michael Wonder on 26 Apr 2022
Treadwell Therapeutics announces fast track designation granted by the FDA to CFI-400945 for the treatment of acute myeloid leukaemia
26 April 2022 - Treadwell Therapeutics announced today that the U.S. FDA has granted fast track designation to CFI-400945, a first ...
Posted by Michael Wonder on 26 Apr 2022
Swissmedic has accepted the new oral edarvarone formulation for the treatment of ALS
25 April 2022 - Mitsubishi Tanabe Pharma announced that Swissmedic has accepted the filing for an investigational oral suspension formalation ...
Posted by Michael Wonder on 26 Apr 2022
ObsEva announces confirmation of positive CHMP opinion for linzagolix, an oral GnRH antagonist, for the treatment of uterine fibroids
25 April 2022 - ObsEva today announced that the CHMP of the EMA has confirmed its previously adopted positive opinion, ...
Posted by Michael Wonder on 25 Apr 2022
FDA approves first COVID-19 treatment for young children
25 April 2022 - Today, the US FDA expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include paediatric ...
Posted by Michael Wonder on 25 Apr 2022
FDA grants regenerative medicine advanced therapy designation to Autolus’ CAR T cell therapy, obe-cel, for the treatment of adult B-ALL
25 April 2022 - Autolus Therapeutics today announced that the U.S. FDA has granted regenerative medicine advanced therapy designation to its ...
Posted by Michael Wonder on 25 Apr 2022
Sol-Gel Technologies and Galderma Announce FDA approval of Epsolay
25 April 2022 - Epsolay (5% benzoyl peroxide topical cream) utilises Sol-Gel’s proprietary microencapsulation technology for the treatment of inflammatory lesions ...
Posted by Michael Wonder on 25 Apr 2022
Tremelimumab accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi
25 April 2022 - STRIDE regimen of a single priming dose of tremelimumab added to Imfinzi is the first dual ...
Posted by Michael Wonder on 25 Apr 2022
Swissmedic grants conditional marketing authorisation for Novavax COVID-19 vaccine
13 April 2022 - Nuvaxovid is the first protein-based COVID-19 vaccine authorised for use in Switzerland. ...
Posted by Michael Wonder on 24 Apr 2022
Update on regulatory submission for aducanumab in the European Union
22 April 2022 - Biogen has notified the EMA of its decision to withdraw its marketing authorisation application for aducanumab for ...