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RSS FeedPosted 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 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 23 Apr 2022
Medexus Pharmaceuticals announces resubmission of treosulfan NDA
22 April 2022 - Additional data collection and analysis reconfirms confidence in new drug application for treosulfan. ...
Posted by Michael Wonder on 23 Apr 2022
Quanterix granted breakthrough device designation from U.S. FDA for NfL test for multiple sclerosis
22 April 2022 - Blood based assay has the potential to serve the multiple sclerosis community in management of relapsing-remitting form ...
Posted by Michael Wonder on 21 Apr 2022
Bridge to Life receives breakthrough device designation from the FDA
21 April 2022 - Bridge to Life advances their perfusion system development with the breakthrough device designation for the LifeCradle ...
Posted by Michael Wonder on 21 Apr 2022
Will the shadow of Aduhelm cloud FDA’s decision-making on an ALS therapy?
21 April 2022 - On March 30, an FDA advisory panel voted 6 to 4 against recommending approval of what ...
Posted by Michael Wonder on 21 Apr 2022
What counts as a breakthrough? 8 insights on the FDA’s approach to medical devices.
21 April 2022 - The word breakthrough carries a kind of weight: it’s a dramatic step forward, a critical advance in ...