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RSS FeedPosted by Michael Wonder on 06 Mar 2023
FDA accepts Eisai's filing of a supplemental biologics license application and grants priority review for traditional approval of Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease
5 March 2023 - Priority Review accelerates FDA review time with a PDUFA target action on 6 July 2023. ...
Posted by Michael Wonder on 02 Mar 2023
Avadel Pharmaceuticals requests final FDA approval for Lumryz (sodium oxybate) extended-release oral suspension
2 March 2023 - Submitted amendment on 1 March 2023 to the Lumryz new drug application seeking final FDA approval. ...
Posted by Michael Wonder on 02 Mar 2023
Verrica Pharmaceuticals announces FDA acceptance of filing of resubmitted NDA for VP-102 for the treatment of molluscum contagiosum
27 February 2023 - Assigns PDUFA goal date of 23 July 2023. ...
Posted by Michael Wonder on 02 Mar 2023
Checkpoint Therapeutics announces FDA filing acceptance of biologics license application for cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma
2 March 2023 - PDUFA goal date of 3 January 2024. ...
Posted by Michael Wonder on 02 Mar 2023
FDA accepts for priority review ADX-2191 new drug application for the treatment of primary vitreoretinal lymphoma
2 March 2023 - PDUFA date is 21 June 2023. ...
Posted by Michael Wonder on 01 Mar 2023
Pfizer and BioNTech submit for US emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 booster in children under 5 years
1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of ...
Posted by Michael Wonder on 01 Mar 2023
Janssen submits new drug application to the US FDA seeking approval of niraparib and abiraterone acetate dual action tablet, plus prednisone, as a first-line targeted treatment for patients with metastatic castration-resistant prostate cancer with BRCA gene mutations
28 February 2023 - Niraparib and abiraterone acetate plus prednisone has potential to address unmet need for patients with BRCA ...
Posted by Michael Wonder on 01 Mar 2023
Cytokinetics receives complete response letter from FDA for new drug application for omecamtiv mecarbil
28 February 2023 - Complete response letter states that GALACTIC-HF alone does not establish substantial evidence of effectiveness sufficient for approval. ...
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 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 ...