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RSS FeedPosted 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
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
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
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, ...
Posted by Michael Wonder on 21 Jun 2023
FDA grants full approval for Blincyto (blinatumomab) to treat minimal residual disease positive B-cell precursor acute lymphoblastic leukaemia
21 June 2023 - Conversion from accelerated to full approval. ...
Posted by Michael Wonder on 21 Jun 2023
argenx announces US FDA approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous use in generalised myasthenia gravis
20 June 2023 - Efficacy of Vyvgart Hytrulo was established by demonstrating a comparable pharmacodynamic effect to Vyvgart in Phase 3 ...
Posted by Michael Wonder on 20 Jun 2023
FDA approves talazoparib with enzalutamide for HRR gene mutated metastatic castration-resistant prostate cancer
20 June 2023 - Today, the FDA approved talazoparib (Talzenna, Pfizer) with enzalutamide for homologous recombination repair (HRR) gene mutated ...
Posted by Michael Wonder on 20 Jun 2023
FDA approves new class of medicines to treat paediatric type 2 diabetes
20 June 2023 - Today, the US FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet ...
Posted by Michael Wonder on 20 Jun 2023
US FDA approves first anti-inflammatory drug for cardiovascular disease
20 June 2023 - Lodoco can reduce the risk of cardiac events in patients with established cardiovascular diseases by 31% on ...
Posted by Michael Wonder on 19 Jun 2023
F2G receives complete response letter from FDA for new drug application for Olorofim for the treatment of invasive fungal infections; plans resubmission with additional data and analyses
19 June 2023 - Complete response letter is related to the request for additional data and analyses. ...
Posted by Michael Wonder on 16 Jun 2023
U.S. Food and Drug Administration approves addition of positive data from Phase 3 VALOR-HCM study to Camzyos (mavacamten) label
15 June 2023 - VALOR-HCM is the second Phase 3 trial in which Camzyos demonstrated significant improvement in symptoms of ...
Posted by Michael Wonder on 16 Jun 2023
FDA approves Genentech’s Columvi, the first and only bispecific antibody with a fixed duration treatment for people with relapsed or refractory diffuse large B-cell lymphoma
15 June 2023 - Pivotal study showed durable responses, with a 56% overall response rate, a 43% complete response (remission) rate, ...
Posted by Michael Wonder on 13 Jun 2023
US FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome
13 June 2023 - Immediate US commercial launch and availability for eligible patients. ...
Posted by Michael Wonder on 12 Jun 2023
FDA approves first treatment for paediatric functional constipation
12 June 2023 - The FDA has approved Linzess (linaclotide) capsules to treat functional constipation in paediatric patients 6 to ...