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RSS FeedPosted by Michael Wonder on 15 Dec 2020
FDA committee to meet again Thursday for Moderna's COVID-19 vaccine
14 December 2020 - A Food and Drug Administration advisory committee will meet for the second time in a week to ...
Posted by Michael Wonder on 15 Dec 2020
U.S. FDA accepts new drug application for review, grants priority review for Takeda’s TAK-721 (budesonide oral suspension) for the treatment of eosinophilic oesophagitis
15 December 2020 - If approved, TAK-721 will be the first FDA approved treatment for the chronic inflammatory disease; Takeda plans ...
Posted by Michael Wonder on 10 Dec 2020
Atox Bio announces FDA acceptance to file the NDA for reltecimod to treat suspected organ dysfunction or failure in patients with necrotising soft tissue infection ("flesh eating disease")
10 December 2020 - Atox Bio today announced that the U.S. FDA has accepted to file the new drug application ...
Posted by Michael Wonder on 10 Dec 2020
Pfizer plans to file for full FDA approval of COVID-19 vaccine in April 2021
11 December 2020 - Pfizer said on Thursday it planned to file for full U.S. approval of its experimental coronavirus ...
Posted by Michael Wonder on 10 Dec 2020
Lantheus Holdings announces acceptance and priority review of new drug application for PyLTM (18F DCFPyL), a PSMA targeted prostate cancer PET imaging agent
9 December 2020 - PDUFA action date of 28 May 2021 assigned by U.S. FDA. ...
Posted by Michael Wonder on 10 Dec 2020
FDA accepts GSK’s filing of Nucala (mepolizumab) for use in chronic rhinosinusitis with nasal polyps
8 December 2020 - If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven ...
Posted by Michael Wonder on 09 Dec 2020
Albireo submits for U.S. FDA and EMA product approval of once daily odevixibat for PFIC
8 December 2020 - Data on PFIC types 1, 2, 3 submitted to support use across a wide range of patients. ...
Posted by Michael Wonder on 09 Dec 2020
US FDA accepts for priority review the biologics license application for Pfizer’s investigational 20 valent pneumococcal conjugate vaccine for adults 18 years of age and older
8 December 2020 - If approved, the vaccine will help protect adults against 20 serotypes responsible for the majority of invasive ...
Posted by Michael Wonder on 07 Dec 2020
Scynexis announces FDA acceptance and priority review of new drug application for oral ibrexafungerp for the treatment of vaginal yeast infections
7 December 2020 - 6 month Priority Review granted for ibrexafungerp with PDUFA target action date set for 1 June 2021. ...
Posted by Michael Wonder on 07 Dec 2020
Chimerix announces FDA acceptance of new drug application for brincidofovir as a medical countermeasure for smallpox
7 December 2020 - Chimerix today announced that the U.S. FDA has accepted the filing of a new drug application ...
Posted by Michael Wonder on 04 Dec 2020
Novo Nordisk files for US FDA regulatory approval of once-weekly semaglutide 2.4 mg for weight management
4 December 2020 - Novo Nordisk today announced the submission of a new drug application to the US FDA for subcutaneous ...
Posted by Michael Wonder on 03 Dec 2020
Genmab announces that Janssen has submitted a biologics license application to U.S. FDA for amivantamab in non-small cell lung cancer
3 December 2020 - First regulatory submission for a DuoBody product candidate. ...
Posted by Michael Wonder on 02 Dec 2020
BridgeBio Pharma and Affiliate QED Therapeutics announce FDA acceptance of new drug application for infigratinib for the treatment of cholangiocarcinoma
1 December 2020 - Application will also be submitted for review in Australia and Canada under Project Orbis. ...
Posted by Michael Wonder on 02 Dec 2020
Amicus Therapeutics initiates rolling biologic license application to the U.S. FDA for AT-GAA in late-onset Pompe disease
1 December 2020 - On track for completing the BLA submission in 1H2021. ...
Posted by Michael Wonder on 02 Dec 2020
TG Therapeutics initiates rolling submission of biologics license application to U.S. FDA for ublituximab in combination with umbralisib as a treatment for patients with chronic lymphocytic leukaemia
1 December 2020 - Completion of rolling submission for the BLA expected in 1H21. ...