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RSS FeedPosted 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 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 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 06 Jul 2023
Astellas announces US FDA grants priority review for zolbetuximab biologics license application
6 July 2023 - Astellas Pharma today announced that the US FDA has accepted and granted priority review for the company’s ...
Posted by Michael Wonder on 03 Jul 2023
Amneal receives US FDA complete response letter for IPX203
3 July 2023 - Letter requests additional pharmacokinetic data. ...
Posted by Michael Wonder on 03 Jul 2023
Celltrion applies for approval in US for eye treatment biosimilar
30 June 2023 - The biopharmaceutical company now covers ophthalmology as well as auto-immune disease and cancer medicine. ...
Posted by Michael Wonder on 01 Jul 2023
Zealand Pharma submits new drug application to US FDA for dasiglucagon in congenital hyperinsulinism
30 June 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for dasiglucagon ...
Posted by Michael Wonder on 01 Jul 2023
Madrigal Pharmaceuticals announces rolling submission of new drug application to US FDA seeking accelerated approval of resmetirom for the treatment of NASH with liver fibrosis
30 June 2023 - Madrigal expects to complete full submission of the new drug application in July 2023. ...
Posted by Michael Wonder on 30 Jun 2023
Formycon announces submission of the biologics license application for FYB203, an aflibercept biosimilar candidate to the US FDA
29 June 2023 - Formycon and its license partner Klinge Biopharma announce that the biologics license application for FYB203, a ...
Posted by Michael Wonder on 29 Jun 2023
Italfarmaco Group completes FDA submission of new drug application for givinostat in Duchenne muscular dystrophy and receives priority review
29 June 2023 - Submission based on completed Phase 3 program in 179 boys demonstrating significant slowing of disease progression with ...
Posted by Michael Wonder on 29 Jun 2023
Alvotech provides regulatory update on second biologics license application for AVT02
28 June 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s second biologics ...
Posted by Michael Wonder on 29 Jun 2023
Eton Pharmaceuticals receives complete response letter for dehydrated alcohol injection
28 June 2023 - Eton Pharmaceuticals announced today that the US FDA issued a complete response letter in response to its ...
Posted by Michael Wonder on 28 Jun 2023
Verona Pharma submits new drug application to US FDA for ensifentrine for the maintenance treatment of COPD
27 June 2023 - Verona Pharma announces the submission of a new drug application to the US FDA for approval ...