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RSS FeedPosted by Michael Wonder on 24 Jul 2023
Overland ADCT BioPharma announces NMPA accepts biologics license application and grants priority review for Zylonta for treatment of relapsed or refractory diffuse large B-cell lymphoma
24 July 2023 - Overland ADCT BioPharma today announced that the China NMPA has accepted the Biologics License Application for ...
Posted by Michael Wonder on 18 Jul 2023
Roche withdraws type II variation for Gazyvaro
18 July 2023 - The EMA has published the letter from Roche on its website. ...
Posted by Michael Wonder on 18 Jul 2023
UCB announces EU regulatory filing for bimekizumab for the treatment of moderate to severe hidradenitis suppurativa
18 July 2023 - Regulatory filing supported by data from two bimekizumab Phase 3 studies in hidradenitis suppurativa. ...
Posted by Michael Wonder on 18 Jul 2023
Madrigal Pharmaceuticals completes submission of new drug application seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis
17 July 2023 - Madrigal Pharmaceuticals announced the completion of the rolling submission of its new drug application to the US ...
Posted by Michael Wonder on 17 Jul 2023
Green Cross resubmits BLA for its immunoglobulin blood product to FDA
17 July 2023 - Green Cross said it has submitted a biologics license application to the US FDA for Alyglo, ...
Posted by Michael Wonder on 17 Jul 2023
Moderna submits authorisation application for coronavirus vaccine Spikevax XBB.1.5
13 July 2023 - Swissmedic examining application for vaccine against Omicron subvariant XBB.1.5 ...
Posted by Michael Wonder on 15 Jul 2023
European Medicine Agency accepts Intas' marketing authorisation application for DMB-3115, a proposed biosimilar to Stelara (ustekinumab)
14 July 2023 - Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global Phase 3 trial. ...
Posted by Michael Wonder on 14 Jul 2023
FDA issues complete response letter for PDP-716 NDA due to inspection findings at third-party API manufacturing facility
13 July 2023 - No issues with clinical efficacy or safety were identified in the complete response letter. ...
Posted by Michael Wonder on 14 Jul 2023
European Medicines Agency accepts Astellas' marketing authorisation application for zolbetuximab
13 July 2023 - Astellas Pharma today announced the EMA has accepted for regulatory review the company's marketing authorisation application for ...
Posted by Michael Wonder on 13 Jul 2023
Dr. Reddy’s proposed rituximab biosimilar application accepted for review by US FDA, EMA and MHRA
12 July 2023 - Following dossier submission in April 2023, the regulatory agencies have now accepted the dossier for review. ...
Posted by Michael Wonder on 12 Jul 2023
BeiGene announces FDA acceptance of sNDA for fifth Brukinsa indication
12 July 2023 - Submission seeks approval for Brukinsa in combination with obinutuzumab as a treatment for relapsed or refractory follicular ...
Posted by Michael Wonder on 12 Jul 2023
Junshi Biosciences announces acceptance of the supplemental new drug application for toripalimab
11 July 2023 - Shanghai Junshi Biosciences announced that the supplemental new drug application for toripalimab, the company’s anti-PD-1 monoclonal antibody, ...
Posted by Michael Wonder on 11 Jul 2023
Xspray Pharma receives request for additional information concerning Dasynoc from FDA
11 July 2023 - Xspray Pharma announces an update on recent developments regarding the company’s first product, Dasynoc, currently under review ...
Posted by Michael Wonder on 11 Jul 2023
Takeda withdraws US application for dengue vaccine candidate
11 July 2023 - Takeda said on Tuesday it was voluntarily withdrawing its application for its dengue vaccine candidate, following ...
Posted by Michael Wonder on 11 Jul 2023
Zai Lab announces acceptance by China’s NMPA of the BLA for efgartigimod alfa injection (subcutaneous injection) for patients with generalised myasthenia gravis
10 July 2023 - Zai Lab today announced that China’s NMPA has accepted the biologics license application for efgartigimod alfa for ...