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RSS FeedPosted by Michael Wonder on 28 Apr 2022
Ultomiris approved in the US for adults with generalised myasthenia gravis
28 April 2022 - First and only long-acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised myasthenia gravis. ...
Posted by Michael Wonder on 28 Apr 2022
FDA grants BTX 1801 new qualified infectious disease product designation status
28 April 2022 - With the recent completion of additional animal studies, the Phase 2 clinical study for BTX 1801 ...
Posted by Michael Wonder on 28 Apr 2022
Nocira becomes first company ever to announce breakthrough device designation by the FDA for acute treatment of migraine
27 April 2022 - Nocira's hand held device that uses gentle, controlled puffs of air in the ears for treating migraine ...
Posted by Michael Wonder on 28 Apr 2022
SQZ Biotechnologies receives FDA fast track designation for its lead cell therapy candidate for the treatment of HPV16 positive tumours
27 April 2022 - Designation Creates Potential to Bring Important New Therapy to Patients Earlier. ...
Posted by Michael Wonder on 27 Apr 2022
Health Canada approves Vraylar (cariprazine) for the treatment of bipolar l disorder and schizophrenia in adults
27 April 2022 - Vraylar is a new atypical antipsychotic medication with partial agonist activity at central dopamine D3 receptors ...
Posted by Michael Wonder on 27 Apr 2022
T2 Biosystems announces submission for FDA breakthrough device designation for T2Biothreat Panel
27 April 2022 - T2 Biosystems announced today that it has submitted an application with the U.S. FDA for breakthrough device ...
Posted by Michael Wonder on 27 Apr 2022
Pfizer and Biohaven's Vydura (rimegapant) granted first ever marketing authorisation by European Commission for both acute treatment of migraine and prophylaxis of episodic migraine
27 April 2022 - Pfizer and Biohaven Pharmaceutical today announced that the European Commission has granted marketing authorisation for Vydura (rimegepant), ...
Posted by Michael Wonder on 27 Apr 2022
European Medicines Agency grants PRIME designation to BioCryst’s ALK-2 inhibitor, BCX9250, for treatment of fibrodysplasia ossificans progressiva
27 April 2022 - BCX9250 is first investigational drug for FOP to be eligible for program. ...
Posted by Michael Wonder on 27 Apr 2022
OncoC4 announces fast track designation granted by the U.S. FDA for ONC-392 monotherapy in PD(L)1 resistant NSCLC
26 April 2022 - OncoC4 announced today that the U.S. FDA has granted fast track designation to ONC-392, the Company’s next-gen ...
Posted 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 ...