Blog
RSS FeedPosted by Michael Wonder on 18 Dec 2024
Merck announces FDA acceptance of biologics license application for clesrovimab, an investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
17 December 2024 - If approved, clesrovimab has the potential to be available to help address the burden of RSV ...
Posted by Michael Wonder on 18 Dec 2024
Jemperli (dostarlimab) receives US FDA breakthrough therapy designation for locally advanced dMMR/MSI-H rectal cancer
16 December 2024 - Designation based on data showing no evidence of disease in 100% of all 42 patients who completed ...
Posted by Michael Wonder on 18 Dec 2024
Tonix Pharmaceuticals announces FDA acceptance of the new drug application for TNX-102 SL for fibromyalgia
17 December 2024 - FDA is expected to assign a PDUFA target action date and announce whether priority review has been ...
Posted by Michael Wonder on 17 Dec 2024
Johnson & Johnson submits application seeking US FDA approval of Simponi (golimumab) for the treatment of paediatric ulcerative colitis
16 December 2024 - Submission aims to expand Simponi ulcerative colitis indication to include paediatric population. ...
Posted by Michael Wonder on 17 Dec 2024
Arcutis submits Zorvye (roflumilast) cream 0.05% supplemental new drug application to the FDA for the treatment of children aged 2 to 5 with mild to moderate atopic dermatitis
16 December 2024 - Zorvye cream 0.05% provided meaningful disease clearance and rapid reduction in itch in pivotal trials. ...
Posted by Michael Wonder on 17 Dec 2024
Update on US regulatory review of subcutaneous amivantamab
16 December 2024 - Johnson & Johnson today announced the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 14 Dec 2024
FDA accepts Ascendis Pharma’s supplemental biologics license application for TransCon hGH for the treatment of adults with growth hormone deficiency
12 December 2024 - PDUFA goal date is 27 July 2025. ...
Posted by Michael Wonder on 13 Dec 2024
Hikma and Richter announce FDA submission acceptance for denosumab biosimilar products
12 December 2024 - Gedeon Richter and Hikma Pharmaceuticals today announced that the US FDA had accepted for review the ...
Posted by Michael Wonder on 12 Dec 2024
Intra-Cellular Therapies submits supplemental new drug application to FDA for Caplyta (lumateperone) for the treatment of major depressive disorder as adjunctive therapy
3 December 2024 - The sNDA submission is based on positive results from Studies 501 and 502 demonstrating Caplyta’s robust anti-depressant ...
Posted by Michael Wonder on 11 Dec 2024
Theratechnologies receives March 2025 PDUFA goal date for updated tesamorelin F8 formulation sBLA
10 December 2024 - Theratechnologies today announced that the US FDA has assigned a PDUFA goal date of 25 March ...
Posted by Michael Wonder on 10 Dec 2024
US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
9 December 2024 - Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations ...
Posted by Michael Wonder on 07 Dec 2024
FDA accepts supplemental biologics license application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
5 December 2024 - Application is based on data from the Phase 3 STARGLO study where Columvi plus chemotherapy showed a ...
Posted by Michael Wonder on 07 Dec 2024
Imfinzi granted priority review in the US for patients with muscle-invasive bladder cancer
6 December 2024 - Decision based on NIAGARA Phase 3 trial results which demonstrated a statistically significant and clinically meaningful ...
Posted by Michael Wonder on 07 Dec 2024
Saol Therapeutics announces submission of new drug application to the US FDA for SL1009
3 December 2024 - Saol Therapeutics today announced the submission of a new drug application to the US FDA for approval ...
Posted by Michael Wonder on 06 Dec 2024
Johnson & Johnson seeks US FDA approval for first paediatric indications for Tremfya (guselkumab)
2 December 2024 - Applications filed for Tremfya to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic ...