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RSS FeedPosted by Michael Wonder on 18 Jul 2022
Acadia Pharmaceuticals submits new drug application to the U.S. FDA for trofinetide for the treatment of Rett syndrome
18 July 2022 - Acadia Pharmaceuticals today announced that the company has submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 18 Jul 2022
Relief Therapeutics announces that its collaboration partner has resubmitted the ACER-001 (sodium phenylbutyrate) new drug application to the FDA for the treatment of urea cycle disorders
18 July 2022 - Relief Therapeutics today announced that its collaboration partner, Acer Therapeutics for ACER-001 (sodium phenylbutyrate) for oral ...
Posted by Michael Wonder on 14 Jul 2022
BeiGene provides regulatory update on the U.S. biologics license application for PD-1 inhibitor tislelizumab in second-line oesophageal squamous cell carcinoma
14 July 2022 - Due to COVID travel restrictions, inspections could not be completed during review period. ...
Posted 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 ...