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RSS FeedPosted by Michael Wonder on 07 Mar 2023
BioMarin provides update on FDA review of Roctavian (valoctocogene roxaparvovec) gene therapy for adults with severe haemophilia A
7 March 2023 - FDA extends PDUFA target action date to 30 June 2023. ...
Posted by Michael Wonder on 07 Mar 2023
Dupixent (dupilumab) application for treatment of chronic spontaneous urticaria in adults and adolescents accepted for FDA review
7 March 2023 - The US FDA has accepted, for review, the supplemental biologics license application for Dupixent (dupilumab) to treat ...
Posted 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 03 Mar 2023
Bayer submits aflibercept 8 mg for marketing authorisation in Japan
1 March 2023 - Submission to the MHLW in Japan for aflibercept 8 mg in neovascular (wet) age-related macular degeneration (nAMD) ...
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 02 Mar 2023
Santhera submits marketing authorisation application to the UK MHRA for vamorolone in Duchenne muscular dystrophy
1 March 2023 - Santhera Pharmaceuticals announces that it has submitted a marketing authorisation application to the UK MHRA for ...
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 28 Feb 2023
CStone announces China’s NMPA has accepted the supplementary new drug application of sugemalimab as first-line treatment for patients with locally advanced or metastatic gastric/gastro-oesophageal junction adenocarcinoma
28 February 2023 - This supplementary new drug application was filed for the fourth indication for sugemalimab in China, following applications ...
Posted by Michael Wonder on 28 Feb 2023
Biologics license application for lecanemab designated for priority review by China NMPA
28 February 2023 - Eisai and Biogen announced today that the biologics license application for lecanemab (brand name in the US: ...