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RSS FeedPosted by Michael Wonder on 27 Feb 2023
SpringWorks Therapeutics announces FDA acceptance and priority review of new drug application for nirogacestat for the treatment of adults with desmoid tumours
27 February 2023 - PDUFA action date set for 27 August 2023. ...
Posted by Michael Wonder on 27 Feb 2023
Glaukos submits new drug application to US FDA for iDose TR
27 February 2023 - Glaukos today announced the submission of its new drug application to the US FDA for iDose® TR. ...
Posted by Michael Wonder on 27 Feb 2023
Pfizer and BioNTech submit supplemental biologics license application for US FDA approval of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine for ages 12 years and older as primary series or booster
24 February 2023 - Pfizer and BioNTech today announced they have submitted a supplemental biologics license application to the US ...
Posted by Michael Wonder on 27 Feb 2023
Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma (CT-P17), in the US, saying there were some problems, but they have been solved now
24 February 2023 - Celltrion has come forward to explain reasons for the delayed approval of its Humira biosimilar, Yuflyma ...
Posted by Michael Wonder on 23 Feb 2023
Arcutis submits roflumilast 0.3% topical foam new drug application to the FDA for the treatment of seborrheic dermatitis in adults and adolescents
21 February 2023 - In a pivotal Phase 3 trial, 80% of individuals treated with roflumilast foam achieved IGA success at ...
Posted by Michael Wonder on 23 Feb 2023
Aflibercept 8 mg BLA for treatment of wet age-related macular degeneration and diabetic macular oedema accepted for FDA priority review
23 February 2023 - BLA supported by two pivotal trials demonstrating non-inferior vision gains to Eylea (aflibercept) Injection, with vast majority ...
Posted by Michael Wonder on 23 Feb 2023
Octapharma USA requests FDA approval for wilate VWD prophylaxis supplement
23 February 2023 - Biologics license application supplement supported by study evaluating efficacy and safety of wilate prophylaxis in adults and ...
Posted by Michael Wonder on 22 Feb 2023
Pfizer’s elranatamab receives FDA and EMA filing acceptance
22 February 2023 - Submissions based on favourable MagnetisMM-3 trial results in patients with relapsed or refractory multiple myeloma. ...
Posted by Michael Wonder on 22 Feb 2023
Imfinzi plus Imjudo approved in the EU for patients with advanced liver and non-small-cell lung cancers
22 February 2023 - Approvals based on significant survival benefits in HIMALAYA and POSEIDON Phase 3 trials. ...
Posted by Michael Wonder on 22 Feb 2023
Optinose submits supplemental new drug application for Xhance label expansion
21 February 2023 - Optinose today announced the submission of its supplemental new drug application to the US FDA to ...
Posted by Michael Wonder on 21 Feb 2023
US FDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
21 February 2023 - US FDA has set an action date for August 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Alnylam announces US FDA acceptance of supplemental new drug application for Onpattro (patisiran) for the treatment of the cardiomyopathy of ATTR amyloidosis
21 February 2023 - PDUFA date set for 8 October 2023. ...
Posted by Michael Wonder on 21 Feb 2023
Pozelimab (C5 antibody) BLA for treatment of children and adults with ultra-rare CHAPLE disease accepted for FDA priority review
21 February 2023 - If approved, pozelimab would be the first and only treatment for those living with CHAPLE. ...
Posted by Michael Wonder on 21 Feb 2023
FDA accepts Orasis Pharmaceuticals' new drug application for CSF-1 for the treatment of presbyopia
21 February 2023 - Investigational, novel eye drop candidate was assigned PDUFA goal date of 22 October 2023. ...
Posted by Michael Wonder on 20 Feb 2023
FDA accepts Valneva’s chikungunya vaccine license application for priority review
20 February 2023 - Valneva today announced that the US FDA has completed a filing review of its biologics license ...