Blog
RSS FeedPosted by Michael Wonder on 14 Jun 2018
Mylan provides statement on generic Advair Diskus
13 June 2018 - On the afternoon of June 13, 2018, Mylan received an update from the U.S. FDA concerning ...
Posted by Michael Wonder on 07 Jun 2018
U.S. FDA and EMA accept regulatory submissions for review of tazaloparib for metastatic breast cancer patients with an inherited BRCA mutation
7 June 2018 - U.S. new drug application granted FDA priority review. ...
Posted by Michael Wonder on 07 Jun 2018
Intra-Cellular Therapies initiates rolling submission of new drug application for lumateperone for treatment of schizophrenia
6 June 2018 - Intra-Cellular Therapies today announced the initiation of a rolling submission of its new drug application with the ...
Posted by Michael Wonder on 05 Jun 2018
FDA grants priority review to Roche’s Hemlibra for people with haemophilia A without factor VIII inhibitors
5 June 2018 - Roche today announced that the US FDA has accepted the company’s supplemental biologics license application and granted ...
Posted by Michael Wonder on 05 Jun 2018
Evoke announces FDA submission of new drug application for Gimoti
4 June 2018 - Evoke Pharma today announced the submission of its 505(b)(2) new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 04 Jun 2018
Palatin Technologies announces FDA acceptance for review of bremelanotide NDA
4 June 2018 - PDUFA target action date 23 March 2019. ...
Posted by Michael Wonder on 01 Jun 2018
Nektar Therapeutics announces submission of a new drug application to the U.S. FDA for NKTR-181, a first-in-class investigational opioid to treat chronic low back pain in adult patients new to opioid therapy
31 May 2018 - Nektar Therapeutics today announced submission of a new drug application to the U.S. FDA for NKTR-181, a ...
Posted by Michael Wonder on 31 May 2018
U.S. FDA designates for priority review Eisai's supplemental new drug application for anti-epiletic drug Fycompa as treatment for paediatric patients with epilepsy
31 May 2018 - Eisai has announced the U.S. FDA has accepted for review the supplemental new drug application for ...
Posted by Michael Wonder on 31 May 2018
Sage Therapeutics announces FDA acceptance of NDA filing and grant of priority review for brexanolone IV in the treatment of post-partum depression
30 May 2018 - If approved, brexanolone IV would be the first and only medication indicated for the treatment of ...
Posted by Michael Wonder on 30 May 2018
Exelixis announces U.S. FDA accepts supplemental new drug application for Cabometyx (cabozantinib) in previously treated advanced hepatocellular carcinoma
30 May 2018 - US FDA assigns Prescription Drug User Fee Act action date of 14 January 2019. ...
Posted by Michael Wonder on 30 May 2018
Celltrion completes resubmission for biosimilar candidate to FDA for review
30 May 2018 - U.S. FDA notified Celltrion of its re-inspection schedule regarding cGMP regular audit. ...
Posted by Michael Wonder on 30 May 2018
Braeburn resubmits opioid use disorder drug CAM2038 for FDA consideration
28 May 2018 - Braeburn announces the resubmission of the new drug application for CAM2038, an investigational buprenorphine flexible-dose weekly and ...
Posted by Michael Wonder on 30 May 2018
Catalyst Pharmaceuticals announces FDA acceptance of NDA and priority review status for Firdapse (amifampridine phosphate) for Lambert-Eaton myasthenic syndrome
29 May 2018 - Catalyst Pharmaceuticals announced today that its new drug application for Firdapse for the treatment of Lambert-Eaton myasthenic ...
Posted by Michael Wonder on 26 May 2018
Eisai and Merck provide update on supplemental new drug application for lenvatinib in first-line unresectable hepatocellular carcinoma
24 May 2018 - Eisai and Merck announced today that the U.S. FDA has extended the action date for the ...
Posted by Michael Wonder on 24 May 2018
Teva confirms September PDUFA date for fremanezumab
23 May 2018 - May 23, 2018-- Teva Pharmaceutical Industries today confirmed that the U.S. FDA has extended the goal date ...