Blog
RSS FeedPosted by Michael Wonder on 03 Dec 2020
Pushed to rush, FDA head says feds will get vaccine 'right'
2 December 2020 - The head of the agency responsible for authorising COVID-19 vaccines says it will take the time needed ...
Posted by Michael Wonder on 03 Dec 2020
Incomplete data stalls Swiss authorisation of COVID-19 vaccines
3 December 2020 - Switzerland’s medical regulator Swissmedic says it lacks the necessary information to sign off on three different coronavirus ...
Posted by Michael Wonder on 02 Dec 2020
Trump to meet next week with industry, government officials on COVID vaccine
2 December 2020 - President Donald Trump will gather leaders from industry and government next week for a summit on the ...
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
What the UK's COVID-19 vaccine means for Australia
2 December 2020 - The race for a COVID-19 vaccine appears to have hit the final stretch, with the UK ...
Posted by Michael Wonder on 02 Dec 2020
COVID-19: Australia on track for Pfizer vaccine in March
2 December 2020 - Health Minister Greg Hunt says the UK’s approval of the Pfizer vaccine, to be rolled out from ...
Posted by Michael Wonder on 02 Dec 2020
TGA statement on UK government emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech
2 December 2020 - The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer ...
Posted by Michael Wonder on 02 Dec 2020
Health Canada licenses Xeomin (incobotulinumtoxinA) for adult patients with sialorrhea
1 December 2020 - Merz Therapeutics today announced Health Canada’s notice of compliance for Xeomin (incobotulinumtoxinA) for the treatment of chronic ...
Posted by Michael Wonder on 02 Dec 2020
FDA approves Hetlioz (tasimelteon) for the treatment of nighttime sleep disturbances in Smith-Magenis syndrome
1 December 2020 - Vanda Pharmaceuticals today announced that the U.S. FDA has approved Hetlioz (tasimelteon) capsule and liquid formulations for ...
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. ...
Posted by Michael Wonder on 01 Dec 2020
Ipsen receives FDA fast track designation for investigational irinotecan liposome injection (Onivyde) as a second-line monotherapy treatment for small cell lung cancer
30 November 2020 - Ipsen today announced the United States FDA has granted the company fast track designation for irinotecan liposome ...
Posted by Michael Wonder on 01 Dec 2020
VBI Vaccines announces submission of biologics license application to FDA for 3 antigen prophylactic hepatitis B vaccine
1 December 2020 - VBI Vaccines today announced the submission of a biologics license application to the U.S. FDA seeking approval ...
Posted by Michael Wonder on 01 Dec 2020
EMA starts rolling review of Janssen’s COVID-19 vaccine Ad26.COV2.S
1 December 2020 - EMA’s CHMP has started a rolling review of Ad26.COV2.S, a COVID-19 vaccine from Janssen-Cilag. ...
Posted by Michael Wonder on 01 Dec 2020
Genentech announces FDA approval of Xolair (omalizumab) for adults with nasal polyps
1 December 2020 - Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E, ...