Blog
RSS FeedPosted by Michael Wonder on 25 Nov 2020
Liquidia receives complete response letter from FDA for LIQ861 (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension
25 November 2020 - Complete response letter does not cite need for additional clinical studies. ...
Posted by Michael Wonder on 25 Nov 2020
Remdesivir (Veklury) approval for the treatment of COVID-19—the evidence for safety and efficacy
26 November 2020 - Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of ...
Posted by Michael Wonder on 25 Nov 2020
Pfizer vaccine distribution could kick off within weeks pending FDA approval, Azar says
24 November 2020 - A FDA panel will meet on 10 December to consider Pfizer’s emergency use authorisation application for its ...
Posted by Michael Wonder on 24 Nov 2020
FDA approves first drug to treat rare metabolic disorder
23 November 2020 - Today, the U.S. FDA approved Oxlumo (lumasiran) as the first treatment for primary hyperoxaluria type 1, a ...
Posted by Michael Wonder on 23 Nov 2020
FDA expands approval of influenza treatment to post-exposure prevention
23 November 2020 - Today, the U.S. FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of ...
Posted by Michael Wonder on 21 Nov 2020
FDA approves first treatment for Hutchinson-Gilford progeria syndrome and some progeroid laminopathies
20 November 2020 - Today, the U.S. FDA approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford ...
Posted by Michael Wonder on 20 Nov 2020
Imfinzi approved in the US for less-frequent, fixed-dose use
20 November 2020 - Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience ...
Posted by Michael Wonder on 20 Nov 2020
FDA authorises drug combination for treatment of COVID-19
19 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the drug baricitinib, in combination with ...
Posted by Michael Wonder on 19 Nov 2020
Lantheus announces FDA approval of Definity room temperature
18 November 2020 - Lantheus today announced the U.S. FDA has approved the supplemental new drug application for Definity Room ...
Posted by Michael Wonder on 18 Nov 2020
Alkermes receives FDA complete response letter related to ALKS 3831 manufacturing records review
17 November 2020 - No clinical efficacy or safety issues raised and no further studies required by FDA to support approval. ...
Posted by Michael Wonder on 18 Nov 2020
FDA authorises first COVID-19 test for self-testing at home
17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...
Posted by Michael Wonder on 17 Nov 2020
UCB’s Vimpat (lacosamide) now approved by FDA in U.S. for primary generalised tonic-clonic seizures and expanded paediatric use for people living with epilepsy
17 November 2020 - All three Vimpat formulations, including injection for intravenous use, are now indicated for the treatment of partial-onset ...
Posted by Michael Wonder on 16 Nov 2020
Adamis Pharmaceuticals receives a complete response letter from the FDA regarding Zimhi
16 November 2020 - Adamis Pharmaceuticals today announced that after the close of business and the U.S. markets on 13 ...
Posted by Michael Wonder on 15 Nov 2020
Agilent receives expanded FDA approval for PD-L1 IHC 22C3 pharmDx in triple negative breast cancer
13 November 2020 - Announcement marks the seventh cancer type for which PD-L1 IHC 22C3 pharmDx has gained approval in the ...
Posted by Michael Wonder on 14 Nov 2020
FDA issues complete response letter for sutimlimab, an investigational treatment for haemolysis in adults with cold agglutinin disease
14 November 2020 - Complete response letter refers to deficiencies from a pre-license inspection of a third-party manufacturing facility. ...