Blog
RSS FeedPosted by Michael Wonder on 11 Nov 2021
US FDA accepts supplemental new drug application and grants priority review for Jardiance for adults with heart failure independent of left ventricular ejection fraction
11 November 2021 - If approved, Jardiance would be the first clinically proven treatment for adults across the full spectrum ...
Posted by Michael Wonder on 07 Nov 2021
Ocugen announces submission of emergency use authorisation request to the US FDA for investigational COVID-19 vaccine Covaxin (BBV152) for children ages 2-18 years
5 November 2021 - Paediatric EUA submission based on immuno-bridging clinical trial in children, ages 2-18, demonstrating comparable neutralising antibody response ...
Posted by Michael Wonder on 03 Nov 2021
Amylyx Pharmaceuticals submits new drug application for AMX0035 for the treatment of ALS
2 November 2021 - Amylyx Pharmaceuticals today announced it has submitted a new drug application to the U.S. FDA for AMX0035 ...
Posted by Michael Wonder on 02 Nov 2021
Junshi Biosciences and Coherus announce FDA acceptance of BLA filing for toripalimab for treatment of nasopharyngeal carcinoma
1 November 2021 - FDA has granted the toripalimab BLA Priority Review with a target action date of April 2022. ...
Posted by Michael Wonder on 02 Nov 2021
Incyte announces acceptance of NDA for parsaclisib for three types of relapsed or refractory non-Hodgkin lymphomas
1 November 2021 - Priority review granted to NDA for relapsed or refractory marginal zone lymphoma and mantle cell lymphoma. ...
Posted by Michael Wonder on 29 Oct 2021
CytoDyn announces FDA accepts revised rolling review timeline for resubmission of its BLA
28 October 2021 - Management expects the non-clinical and CMC sections of the BLA to be resubmitted to FDA in ...
Posted by Michael Wonder on 28 Oct 2021
Spero Therapeutics submits new drug application to U.S. FDA for tebipenem hydrobromide for the treatment of complicated urinary tract infections including pyelonephritis
28 October 2021 - Spero Therapeutics today announced the submission of a new drug application to the U.S. FDA, seeking approval ...
Posted by Michael Wonder on 28 Oct 2021
Be careful who you sue: CytoDyn knowingly submitted an incomplete drug application to FDA, new documents show
28 October 2021 - CytoDyn and its CEO Nader Pourhassan have known the company’s long delayed HIV drug was in ...
Posted by Michael Wonder on 27 Oct 2021
Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah to treat patients with relapsed or refractory follicular lymphoma
27 October 2021 - Filings supported by pivotal ELARA trial, where treatment with Kymriah showed robust response rates and remarkable safety ...
Posted by Michael Wonder on 26 Oct 2021
Lilly pipeline success strengthens future growth potential
27 October 2021 - Lilly announces today its U.S. submission of tirzepatide in type 2 diabetes using a priority review ...
Posted by Michael Wonder on 22 Oct 2021
Agenus provides update on balstilimab development
22 October 2021 - Company voluntarily withdraws biologics license application at FDA’s recommendation following full approval of pembrolizumab, which came four months ...
Posted by Michael Wonder on 20 Oct 2021
Stealth BioTherapeutics receives refusal to file letter from the FDA
20 October 2021 - Stealth BioTherapeutics today announced that it received a Refusal to File letter from the United States FDA ...
Posted by Michael Wonder on 18 Oct 2021
Avadel Pharmaceuticals announces ongoing FDA review of NDA for FT218 for patients with narcolepsy
15 October 2021 - Avadel Pharmaceuticals announced today that the U.S. FDA notified the company that the review of the new ...
Posted by Michael Wonder on 14 Oct 2021
FDA accepts Regen-Cov (casirivimab and imdevimab) for priority review for treatment and prophylaxis of COVID-19
14 October 2021 - European Medicines Agency also announced earlier this week it would review marketing authorisation application for the antibody ...
Posted by Michael Wonder on 11 Oct 2021
Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults
11 October 2021 - Submissions to regulatory agencies worldwide underway. ...