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RSS FeedPosted by Michael Wonder on 29 Apr 2022
Rinvoq (upadacitinib) approved by U.S. FDA as an oral treatment for adults with active ankylosing spondylitis
29 April 2022 - Across the two pivotal trials, Rinvoq delivered rapid and meaningful disease control with nearly half of ankylosing ...
Posted by Michael Wonder on 29 Apr 2022
Fennec Pharmaceuticals announces FDA acceptance for filing of new drug application resubmission for Pedmark
27 April 2022 - Prescription Drug User Fee Act target action date set for 23 September 2022. ...
Posted by Michael Wonder on 29 Apr 2022
U.S. Food and Drug Administration approves Camzyos (mavacamten) for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms
28 April 2022 - Camzyos is the first and only FDA approved cardiac myosin inhibitor that specifically targets the source of ...
Posted by Michael Wonder on 29 Apr 2022
Timber Pharmaceuticals announces fast track designation granted by FDA for TMB-001 in severe subtypes of congenital ichthyosis
28 April 2022 - Company expects to launch pivotal Phase 3 ASCEND clinical trial to evaluate TMB-001 within the next ...
Posted by Michael Wonder on 29 Apr 2022
Moderna files for authorisation of its COVID-19 vaccine in young children six months to under six years of age
28 April 2022 - Submission to regulators globally is based on Phase 2/3 studies of mRNA-1273 in young children. ...
Posted by Michael Wonder on 28 Apr 2022
FDA approves Mycovia Pharmaceuticals’ Vivjoa (oteseconazole), the first and only FDA approved medication for recurrent vulvovaginal candidiasis
28 April 2022 - U.S. commercial launch of Vivjoa expected in Q2, ...
Posted 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
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
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 ...