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RSS FeedPosted by Michael Wonder on 27 Jun 2023
FDA issues complete response letter for aflibercept 8 mg biologics license application solely due to an on-going review of inspection findings at a third-party filler
27 June 2023 - No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in ...
Posted by Michael Wonder on 27 Jun 2023
UCB provides update on US FDA review of the biologics license application for bimekizumab
26 June 2023 - UCB today announced that the biologics license application for bimekizumab for the treatment of adults with ...
Posted by Michael Wonder on 27 Jun 2023
AC Immune receives FDA fast track designation for anti-amyloid beta active immunotherapy, ACI-24.060, to treat Alzheimer’s disease
27 June 2023 - Initial PET data on amyloid plaque reduction in Alzheimer's disease expected H1, 2024. ...
Posted by Michael Wonder on 27 Jun 2023
FDA accepts Pfizer’s application for haemophilia B gene therapy fidanacogene elaparvovec
27 June 2023 - Submissions based on positive Phase 3 data from BENEGENE-2 trial. ...
Posted by Michael Wonder on 27 Jun 2023
GSK receives US FDA fast track designation for investigational vaccine against gonorrhoea
27 June 2023 - Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to ...
Posted by Michael Wonder on 27 Jun 2023
UCB announces US FDA approval of Rystiggo (rozanolixizumab-noli) for the treatment of adults with generalised myasthenia gravis
27 June 2023 - US FDA approval is based on the pivotal Phase 3 MycarinG study in gMG2, a large phase ...
Posted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...
Posted by Michael Wonder on 24 Jun 2023
FDA approves Pfizer’s Litfulo (ritlecitinib) for adults and adolescents with severe alopecia areata
23 June 2023 - Litfulo is the first and only treatment for severe alopecia areata approved for patients as young ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 23 Jun 2023
Intercept receives complete response letter from FDA for obeticholic acid as a treatment for pre-cirrhotic fibrosis due to NASH
22 June 2023 - Company to discontinue all NASH-related investment and restructure the Company’s operations to strengthen its focus on rare ...
Posted by Michael Wonder on 22 Jun 2023
Anumana receives US FDA breakthrough device designation for its cardiac amyloidosis algorithm
21 June 2023 - Developed in collaboration with Mayo Clinic, with support from Pfizer, this ECG-AI algorithm aims to aid ...
Posted by Michael Wonder on 22 Jun 2023
Cidara Therapeutics receives US FDA fast track designation for CD388, a novel drug-FC conjugate targeting influenza A and B
22 June 2023 - Cidara Therapeutics today announced that the US FDA has granted fast track designation to CD388, Cidara’s novel ...
Posted by Michael Wonder on 22 Jun 2023
Transitional coverage for emerging technologies
22 June 2023 - The Centers for Medicare & Medicaid Services issued a proposed procedural notice outlining a new Medicare coverage ...
Posted by Michael Wonder on 22 Jun 2023
FDA approves first gene therapy for treatment of certain patients with Duchenne muscular dystrophy
22 June 2023 - Today, the US FDA approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 ...
Posted by Michael Wonder on 22 Jun 2023
Aldeyra Therapeutics provides regulatory update on ADX-2191
21 June 2023 - Based on US FDA determination of lack of adequate and well controlled investigations in the scientific literature, ...