Blog
RSS FeedPosted by Michael Wonder on 20 May 2022
AbbVie submits new drug application to U.S. FDA for investigational ABBV-951 (foscarbidopa/foslevodopa) for the treatment of advanced Parkinson's disease
20 May 2022 - Submission is supported by Phase 3 study that demonstrated patients had significant increases in hours of ...
Posted by Michael Wonder on 04 May 2022
Phathom Pharmaceuticals announces FDA approval of Voquenza Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquenza Dual Pak (vonoprazan, amoxicillin) for the treatment of H. pylori infection in adults
3 May 2022 - U.S. commercial launch anticipated in the third quarter of 2022. ...
Posted by Michael Wonder on 14 Apr 2022
U.S. FDA extends review of biologics license application for Regen-Cov (casivirimab and imdemivab) for treatment and prophylaxis of COVID-19
14 April 2022 - Regeneron continues to progress its next generation antibodies, and has initiated a first in human trial. ...
Posted by Michael Wonder on 31 Mar 2022
ViiV Healthcare announces US FDA approval of Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV
30 March 2022 - The FDA approval of the first dispersible single tablet regimen containing dolutegravir increases age-appropriate treatment options ...
Posted by Michael Wonder on 20 Mar 2022
U.S. Food and Drug Administration approves first LAG-3 blocking antibody combination, Opdualag (nivolumab and relatlimab-rmbw), as treatment for patients with unresectable or metastatic melanoma
18 March 2022 - Opdualag is a first in class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor nivolumab and ...
Posted by Michael Wonder on 15 Mar 2022
FDA approves first generic of Symbicort to treat asthma and COPD
15 March 2022 - Agency supports development of complex generic drug-device combination product to improve competition and access to more affordable ...
Posted by Michael Wonder on 16 Jan 2022
Glenmark receives NDA approval by the United States FDA for Ryaltris nasal spray for the treatment of symptoms of seasonal allergic rhinitis in adults and paediatric patients 12 years of age and older
14 January 2022 - Ryaltris will be marketed and distributed in the United States through its partner Hikma. ...
Posted by Michael Wonder on 31 Dec 2021
Amylyx Pharmaceuticals announces FDA acceptance and priority review of new drug application for AMX0035 for the treatment of ALS
29 December 2021 - Amylyx Pharmaceuticals today announced that the U.S. FDA has accepted for review its new drug application for ...
Posted by Michael Wonder on 13 Dec 2021
Veru announces FDA approval of Entadfi, a new treatment for benign prostatic hyperplasia
13 December 2021 - Commercialisation will start early calendar year 2022. ...
Posted by Michael Wonder on 09 Dec 2021
Heron Therapeutics announces FDA approval of a significant indication expansion for Zynrelef
9 December 2021 - Approval provides a significantly broader indication for Zynrelef, now covering approximately 7 million procedures a year. ...
Posted by Michael Wonder on 18 Oct 2021
U.S. Food and Drug Administration approves expanded indication of Gilead’s Biktarvy for treatment of HIV-1 in paediatric populations
18 October 2021 - FDA approves low dose tablet for HIV treatment in virologically suppressed children weighing at least 14 kg. ...
Posted by Michael Wonder on 14 Sep 2021
Axsome Therapeutics announces FDA acceptance of new drug application for AXS-07 for the acute treatment of migraine
14 September 2021 - Axsome Therapeutics today announced that the U.S. FDA has accepted for filing the Company’s new drug application ...
Posted by Michael Wonder on 12 Aug 2021
FDA grants first of its kind indication for chronic sleep disorder treatment
12 August 2021 - The U.S. Food and Drug Administration today approved a new indication for Xywav for idiopathic hypersomnia in ...
Posted by Michael Wonder on 12 Aug 2021
Jazz Pharmaceuticals announces U.S. FDA approval of Xywav (calcium, magnesium, potassium and sodium oxybates) oral solution for idiopathic hypersomnia in adults
12 August 2021 - Xywav is the first and only FDA approved treatment for idiopathic hypersomnia. ...
Posted by Michael Wonder on 27 Jul 2021
Sol-Gel Technologies announces FDA approval of Twyneo
27 July 2021 - Twyneo utilizes Sol-Gel’s proprietary microencapsulation technology and is patent protected until 2038. ...