Blog
RSS FeedPosted 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 04 Jul 2023
Moderna submits regulatory application to the EMA for its updated COVID-19 vaccine
3 July 2023 - The filing follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 ...
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 30 Jun 2023
Moderna initiates rolling submission to Health Canada for updated COVID-19 vaccine
29 June 2023 - Health Canada submission follows international recommendations to develop monovalent XBB.1.5 COVID-19 vaccines. ...
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
Zai Lab announces NDA acceptance of repotrectinib for patients with ROS1 positive NSCLC by China’s NMPA
28 June 2023 - Zai Lab today announced that the National Medical Products Administration (NMPA) in China has accepted the New ...
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
Merck, Ridgeback withdraw COVID drug application in EU
27 June 2023 - Merck and partner Ridgeback Biotherapeutics said on Tuesday they had withdrawn their COVID-19 pill application in ...
Posted by Michael Wonder on 28 Jun 2023
Bristol Myers Squibb receives European Commission approval of Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy
26 June 2023 - Approval based on two positive Phase 3 trials, EXPLORER-HCM and VALOR-HCM, demonstrating significant benefit in patients ...
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 ...