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RSS FeedPosted by Michael Wonder on 21 Jun 2023
CorMedix announces FDA acceptance of resubmission of new drug application for DefenCath
21 June 2023 - CorMedix today announced that the resubmission of the new drug application for DefenCath has been accepted for ...
Posted by Michael Wonder on 21 Jun 2023
Xbrance announce US FDA filing acceptance for a Lucentis (ranibizumab) biosimilar candidate
21 June 2023 - Xbrane Biopharma today announced the acceptance of the supplemental biologics license application for a Lucentis (ranibizumab) biosimilar ...
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 21 Jun 2023
Novo Nordisk takes actions to help protect US patients from unlawful sales of non-FDA approved medicines claiming to contain semaglutide
20 June 2023 - Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and ...
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
Geron announces submission of new drug application to FDA for first in class telomerase inhibitor imetelstat
20 June 2023 - Geron today announced the submission to the US FDA of a new drug application for imetelstat for ...
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
GSK announces extension of FDA review period for momelotinib
16 June 2023 - GSK today announced that the US FDA has extended the review period of the new drug application ...
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 15 Jun 2023
Coherus resolves part of dispute with AbbVie over Humira biosimilar
16 June 2023 - Coherus BioSciences said on Thursday it had agreed to retract a restraining order against AbbVie as ...
Posted by Michael Wonder on 15 Jun 2023
New Alzheimer’s drug is a problem for FDA’s pass-fail approach
15 June 2023 - The FDA is slated to soon give full approval to Leqembi, a new medicine for Alzheimer’s disease ...
Posted by Michael Wonder on 15 Jun 2023
Amneal receives NDA approval from FDA for Pemrydi RTU, a ready to use oncology injectable
14 June 2023 - Adds first ready to use presentation of key injectable for treating non-squamous non-small cell lung cancer and ...