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RSS FeedPosted by Michael Wonder on 18 May 2020
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA
18 May 2020 - Adamis Pharmaceuticals Corporation today announced the resubmission of the Company’s new drug application to the U.S. ...
Posted by Michael Wonder on 14 May 2020
Sunovion discontinues dasotraline program
13 May 2020 - Sunovion Pharmaceuticals today announced that it has withdrawn the new drug applications for dasotraline, a novel ...
Posted by Michael Wonder on 13 May 2020
Arbor Pharmaceuticals announces FDA filing acceptance of new drug application for AR19, an investigational ADHD prescription stimulant treatment specifically designed to resist physical manipulation for non-medical misuse or abuse
13 May 2020 - If approved, AR19 would be the first-ever FDA approved ADHD stimulant medication designed to resist manipulation for ...
Posted by Michael Wonder on 13 May 2020
Vanda Pharmaceuticals announces agreement with FDA on resubmission of the application for Hetlioz for the treatment of patients with Smith-Magenis syndrome
13 May 2020 - Vanda Pharmaceuticals today announced that following the completion of a Type A meeting with the U.S. FDA ...
Posted by Michael Wonder on 13 May 2020
Rhythm Pharmaceuticals announces FDA acceptance of new drug application for setmelanotide for the treatment of POMC and LEPR deficiency obesities
13 May 2020 - FDA grants priority review of application and sets PDUFA goal date of 27 November 2020. ...
Posted by Michael Wonder on 13 May 2020
Bristol Myers Squibb and bluebird bio provide regulatory update on idecabtagene vicleucel (ide-cel, bb2121) for the treatment of patients with multiple myeloma
Bristol Myers Squibb and bluebird bio today announced that the companies received a Refusal to File letter from the U.S. ...
Posted by Michael Wonder on 10 May 2020
CytoDyn clarifies status of biologics license application
8 May 2020 - CytoDyn today further clarified the status of the Company’s submission of its biologics license application to the ...
Posted by Michael Wonder on 06 May 2020
Bristol Myers Squibb provides update on biologics license application for lisocabtagene maraleucel
6 May 2020 - Bristol Myers Squibb today announced that the U.S. FDA has extended the action date by three ...
Posted by Michael Wonder on 06 May 2020
Chiesi files resubmission to address FDA Bronchitol (mannitol) inhalation powder complete response letter
5 May 2020 - Pharmaxis today announced its US licensee Chiesi has filed a resubmission that addresses the issues raised ...
Posted by Michael Wonder on 06 May 2020
Kala Pharmaceuticals resubmits new drug application for Eysuvis for dry eye disease
4 May 2020 - Kala Pharmaceuticals today announced that it has resubmitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 04 May 2020
NDA filing for potential new ADHD treatment, KP415, accepted by FDA
4 May 2020 - Corium, GPC’s portfolio company, to lead all commercialisation activities for KP415. ...
Posted by Michael Wonder on 27 Apr 2020
CytoDyn submits completed biologics license application to the FDA for leronlimab as a combination therapy for highly treatment experienced HIV patients
27 April 2020 - During the FDA’s review period, the Company will dedicate all resources to ensure availability of leronlimab for ...
Posted by Michael Wonder on 26 Apr 2020
Janssen announces submission of two applications to U.S. FDA seeking approval of Simponi Aria (golimumab) for the treatment of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
24 April 2020 - Submissions demonstrate Janssen’s commitment to developing new options for young patients. ...
Posted by Michael Wonder on 25 Apr 2020
Merck resubmits supplemental biologics license applications for Keytruda (pembrolizumab) six week dosing schedule
23 April 2020 - Additional applications filed across all approved adult indications. ...
Posted by Michael Wonder on 22 Apr 2020
Mallinckrodt announces U.S. FDA filing acceptance of new drug application for terlipressin for treatment of hepatorenal syndrome type 1
22 April 2020 - Terlipressin would be the first FDA approved treatment option in the United States for adult patients with ...