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RSS FeedPosted by Michael Wonder on 01 Mar 2023
Kevzara (sarilumab) approved by FDA as first and only biologic indicated for patients with polymyalgia rheumatica
28 February 2023 - Three times more patients treated with Kevzara achieved sustained remission compared to placebo in Phase 3 trial. ...
Posted by Michael Wonder on 01 Mar 2023
Reata Pharmaceuticals announces FDA approval of Skyclarys (omavaloxolone), the first and only drug indicated for patients with Friedreich’s ataxia
28 February 2023 - Rare paediatric disease priority review voucher granted. ...
Posted by Michael Wonder on 28 Feb 2023
US FDA accepts Bristol Myers Squibb’s supplemental biologics license application and EMA validates application for Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected stage IIB or IIC melanoma
28 February 2023 - The applications are based on results from the Phase 3 CheckMate-76K trial, in which Opdivo demonstrated a ...
Posted by Michael Wonder on 28 Feb 2023
My son’s time is running out due to a rare disease. The FDA needs to add more clinical trial flexibility.
28 February 2023 - My toddler, Wheeler, will probably not live to adulthood. Juvenile Batten disease — he has the ...
Posted 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
For Cytokinetics, an FDA rejection of its heart drug would help, not hinder
27 February 2023 - Cytokinetics was founded 26 years ago but has not yet developed a drug successfully to approval. ...
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
US Medicare says no change to Alzheimer's drug restrictions
23 February 2023 - The US Government health plan for people over the age of 65 on Wednesday said it ...
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
Moderna and Merck announce mRNA-4157/V940, an investigational personalised mRNA cancer vaccine, in combination with pembrolizumab, was granted breakthrough therapy designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection
22 February 2023 - Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial. ...
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
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
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. ...