Blog
RSS FeedPosted 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
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
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, ...
Posted by Michael Wonder on 01 Dec 2020
US hopeful of pre-Christmas COVID jab, Australia still has long wait
1 December 2020 - Millions of vulnerable Americans could be vaccinated against coronavirus before the end of 2020 but it ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves pralsetinib for RET altered thyroid cancers
1 December 2020 - Today the Food and Drug Administration approved pralsetinib (Gavreto, Blueprint Medicines) for adult and pediatric patients ...
Posted by Michael Wonder on 01 Dec 2020
FDA approves first PSMA-targeted PET imaging drug for men with prostate cancer
1 December 2020 - Today, the U.S. FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for ...
Posted by Michael Wonder on 01 Dec 2020
Kadmon announces FDA acceptance of NDA for belumosudil in patients with chronic graft versus host disease
30 November 2020 - Application being evaluated Under FDA's Real-Time Oncology Review and Project Orbis pilot programs. ...
Posted by Michael Wonder on 01 Dec 2020
Karolinska Development's portfolio company Aprea Therapeutics receives FDA fast track designation for eprenetapopt in AML
30 November 2020 - Karolinska Development announces today that the U.S. FDA has granted fast track designation for eprenetapopt in the ...
Posted by Michael Wonder on 30 Nov 2020
Zymeworks receives FDA breakthrough therapy designation for HER2-targeted bispecific antibody zanidatamab in patients with biliary tract cancer
30 November 2020 - Zymeworks today announced that the U.S. FDA has granted breakthrough therapy designation for zanidatamab in patients with ...
Posted by Michael Wonder on 30 Nov 2020
Moderna submits vaccine for FDA regulatory approval
30 November 2020 - Recent vaccine developments have been met with optimism among scientists and stock markets, but experts also urge ...
Posted by Michael Wonder on 30 Nov 2020
Pharmacies add freezers, train staff to handle COVID-19 vaccination drive
29 November 2020 - Many supermarkets have offered customers flu shots for years, but COVID-19 vaccine distribution will require more coordination ...
Posted by Michael Wonder on 30 Nov 2020
Deploying big data to determine how well vaccines work
29 November 2020 - As the initial rollout starts, it’s time to start planning a registry to monitor health outcomes. ...