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RSS FeedPosted by Michael Wonder on 21 Jun 2024
FDA grants accelerated approval to adagrasib with cetuximab for KRAS G12C mutated colorectal cancer
21 June 2024 - Today, the FDA granted accelerated approval to adagrasib (Krazati; Mirati Therapeutics) plus cetuximab for adults with ...
Posted by Michael Wonder on 20 Jun 2024
FDA expands approval of gene therapy for patients with Duchenne muscular systrophy
20 June 2024 - Today, the FDA expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment ...
Posted by Michael Wonder on 20 Jun 2024
FDA approval of Sofdra - the first new drug for primary axillary hyperhidrosis
20 June 2024 - FDA approval was supported by results from the two pivotal Phase 3 studies evaluating the efficacy ...
Posted by Michael Wonder on 19 Jun 2024
US FDA approves Skyrizi (risankizumab-rzaa) for ulcerative colitis, expanding AbbVie's portfolio across inflammatory bowel disease
18 June 2024 - Approval supported by two Phase 3 clinical trials that evaluated Skyrizi for the treatment of moderate to ...
Posted by Michael Wonder on 18 Jun 2024
Grifols’ Biotest receives FDA approval for innovative Yimmugo immunoglobulin to treat primary immunodeficiencies
17 June 2024 - Launching Yimmugo in the US will over time significantly add to Grifols Group sales and underpins ...
Posted by Michael Wonder on 18 Jun 2024
US FDA approves Capvaxive (pneumococcal 21 valent conjugate vaccine) for prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults
17 June 2024 - Capvaxive (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal ...
Posted by Michael Wonder on 17 Jun 2024
FDA approves pembrolizumab with chemotherapy for primary advanced or recurrent endometrial carcinoma
17 June 2024 - Today, the FDA approved pembrolizumab (Keytruda, Merck) with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for ...
Posted by Michael Wonder on 14 Jun 2024
FDA approves blinatumomab as consolidation for CD19 positive Philadelphia chromosome negative B-cell precursor acute lymphoblastic leukaemia
14 June 2024 - Today, the FDA approved blinatumomab (Blincyto, Amgen) for adult and paediatric patients one month and older ...
Posted by Michael Wonder on 14 Jun 2024
FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer
14 June 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with carboplatin plus paclitaxel followed by single-agent durvalumab for ...
Posted by Michael Wonder on 13 Jun 2024
FDA approves Adbry (tralokinumab-ldrm) auto-injector for the treatment of adults with moderate to severe atopic dermatitis
13 June 2024 - Single-dose auto-injector will provide adult patients in the US with an alternative method of administration for Adbry, ...
Posted by Michael Wonder on 13 Jun 2024
FDA grants accelerated approval to repotrectinib for adult and paediatric patients with NTRK gene fusion positive solid tumours
13 June 2024 - Today, the FDA granted accelerated approval to repotrectinib (Augtyro, BMS) for adult and paediatric patients 12 ...
Posted by Michael Wonder on 13 Jun 2024
Receipt of complete response letter from US FDA for ND0612
11 June 2024 - Mitsubishi Tanabe Pharma today announced that the US FDA has issued a complete response letter for ...
Posted by Michael Wonder on 13 Jun 2024
FDA approves selpercatinib for RET fusion positive thyroid cancer
12 June 2024 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and paediatric patients ...
Posted by Michael Wonder on 12 Jun 2024
Farxiga approved in the US for the treatment of paediatric type 2 diabetes mellitus
12 June 2024 - Approval based on results from T2NOW, one of the largest paediatric type 2 diabetes Phase 3 ...
Posted by Michael Wonder on 11 Jun 2024
Kevzara (sarilumab) approved by FDA for the treatment of active polyarticular juvenile idiopathic arthritis
11 June 2024 - Approval in patients with pJIA weighing 63 kg or greater adds to Kevzara’s position in treating ...