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RSS FeedPosted by Michael Wonder on 11 Dec 2020
Pfizer and BioNTech receive FDA Advisory Committee vote supporting potential first emergency use authorisation for vaccine to combat COVID-19 in the U.S
10 December 2020 - FDA expected to make a decision on Emergency Use Authorization in the coming days. ...
Posted by Michael Wonder on 10 Dec 2020
SoniVie receives FDA breakthrough device designation for the TIVUS system for renal artery denervation
9 December 2020 - SoniVie acquires new intellectual property and other assets from Cardiosonic Moving TIVUS into new therapeutic areas beyond ...
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
Federal watchdog urged to investigate the FDA’s handling of Biogen Alzheimer’s drug
9 December 2020 - A federal watchdog is being asked to investigate the FDA for an “inappropriate collaboration” with Biogen ...
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
FDA holds advisory committee meeting to discuss authorisation of COVID-19 vaccine candidate as part of Agency’s review of safety and effectiveness data
10 December 2020 - The following is attributed to FDA Commissioner Stephen M. Hahn. ...
Posted by Michael Wonder on 10 Dec 2020
X4 Pharmaceuticals receives rare paediatric disease designation from FDA for mavorixafor for the treatment of WHIM syndrome
10 December 2020 - X4 Pharmaceuticals today announced that it has received rare paediatric disease designation from the U.S. FDA ...
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
ReGelTec receives FDA breakthrough designation for its Hydrafil system
9 December 2020 - ReGelTec announced today that it has received breakthrough device designation from the Center for Devices and Radiological ...
Posted by Michael Wonder on 09 Dec 2020
Amgen's sotorasib granted breakthrough therapy designation for advanced or metastatic non-small cell lung cancer patients with KRAS G12C mutation
8 December 2020 - Sotorasib also accepted into FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 09 Dec 2020
COVID-19 vaccine trial deaths were not related to treatment: Pfizer
9 December 2020 - Two people who received Pfizer’s experimental COVID-19 vaccine died during clinical trials, but the pharma giant says ...
Posted by Michael Wonder on 09 Dec 2020
Blunders eroded U.S. confidence in early vaccine front-runner
8 December 2020 - The Oxford-AstraZeneca effort held great promise to help arrest the pandemic. But a series of miscues caused ...
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 ...