Blog
RSS FeedPosted by Michael Wonder on 12 Jul 2022
FDA accepts Byondis' biologics license application for [vic-] trastuzumab duocarmazine (SYD985) in HER2 positive metastatic breast cancer
12 July 2022 - Submission follows positive results of Phase 3 TULIP trial. ...
Posted by Michael Wonder on 11 Jul 2022
Perrigo's HRA Pharma submits application to FDA for first ever OTC birth control pill
11 July 2022 - Perrigo today announced that HRA Pharma, a Perrigo company, has submitted its application to the U.S. ...
Posted by Michael Wonder on 10 Jul 2022
New drug application for treatment of dry eyes disease submitted to FDA
7 July 2022 - A treatment for dry eye symptoms associated with Meibomian gland dysfunction has been submitted under a ...
Posted by Michael Wonder on 06 Jul 2022
Junshi Biosciences and Coherus announce FDA acceptance of resubmission of BLA for toripalimab for the treatment of nasopharyngeal carcinoma
6 July 2022 - The FDA has set a target action date of 23 December 2022 for the toripalimab BLA. ...
Posted by Michael Wonder on 06 Jul 2022
The U.S. FDA accepts and grants priority review for Eisai's biologics license application of lecanemab for early Alzheimer's disease under the accelerated approval pathway
6 July 2022 - Eisai and Biogen announced today that the U.S. FDA has accepted the biologics license application under the ...
Posted by Michael Wonder on 01 Jul 2022
US FDA seeks more information on Maxigesic IV application
1 July 2022 - Hyloris Pharmaceuticals announces that it has today received a complete response letter from the US FDA on ...
Posted by Michael Wonder on 30 Jun 2022
Pfizer announces submission of new drug application to the U.S. FDA for Paxlovid
30 June 2022 - Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalisations or death from ...
Posted by Michael Wonder on 29 Jun 2022
Eylea (aflibercept) injection sBLA for every 16 week dosing regimen in patients with diabetic retinopathy accepted for FDA review
29 June 2022 - If approved, extended regimen would provide a longer treatment interval and additional dosing flexibility, alongside approved ...
Posted by Michael Wonder on 29 Jun 2022
Ipsen announces U.S. FDA priority review for palovarotene new drug application in patients with fibrodysplasia ossificans progressiva following resubmission
29 June 2022 - Ipsen today announced that the U.S. FDA has accepted for priority review its resubmitted new drug ...
Posted by Michael Wonder on 28 Jun 2022
Apnimed granted FDA fast track designation for AD109, a novel first in class oral pharmacologic combination for the treatment of obstructive sleep apnoea
28 June 2022 - Additional Phase 2b data evaluating AD109 as potential treatment for obstructive sleep apnoea anticipated in Q3 ...
Posted by Michael Wonder on 28 Jun 2022
Gilead resubmits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor
27 June 2022 - NDA Resubmission Addresses Issues Related to Vial Compatibility. ...
Posted by Michael Wonder on 26 Jun 2022
Emergent BioSolutions announces FDA acceptance of biologics license application for AV7909 anthrax vaccine candidate
24 June 2022 - Emergent BioSolutions announced today that the U.S. FDA accepted for review the biologics license application for AV7909 ...
Posted by Michael Wonder on 24 Jun 2022
Astellas submits fezolinetant new drug application to U.S. FDA
24 June 2022 - Application targets treatment of moderate to severe vasomotor symptoms associated with menopause ...
Posted by Michael Wonder on 23 Jun 2022
Menarini Group and Radius Health submit new drug application to the U.S. FDA for elacestrant
22 June 2022 - Priority review requested; if accepted, anticipate an 8 month FDA review. ...
Posted by Michael Wonder on 22 Jun 2022
Krystal Biotech submits biologics license application to U.S. FDA seeking approval of B-VEC for the treatment of patients with dystrophic epidermolysis bullosa
22 June 2022 - Krystal Biotech announced today the submission of a biologics license application to the U.S. FDA seeking ...