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RSS FeedPosted by Michael Wonder on 12 Jan 2022
Idorsia receives US FDA approval of Quviviq (daridorexant) 25 and 50 mg for the treatment of adults with insomnia
10 January 2022 - The approval of Quviviq – 25 & 50 mg – is based on a robust Phase 3 ...
Posted by Michael Wonder on 11 Jan 2022
FDA approved more first in class drugs, gave more accelerated approvals in 2021
7 January 2022 - The US Food and Drug Administration’s Center for Drug Evaluation and Research approved 50 new drug therapies ...
Posted by Michael Wonder on 11 Jan 2022
Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant
11 January 2022 - EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years
11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Lumykras (sotorasib) for patients with KRAS G12C mutated advanced non-small cell lung cancer
10 January 2022 - Approval based on pivotal CodeBreaK 100 data demonstrating durable responses and a favourable benefit-risk profile with Lumykras ...
Posted by Michael Wonder on 11 Jan 2022
CARsgen announces CT041 CAR T-cell product candidate granted RMAT designation by the FDA
10 January 2022 - CARsgen Therapeutics today announced that the US FDA granted regenerative medicine advanced therapy designation to CT041 for ...
Posted by Michael Wonder on 11 Jan 2022
SIGA Technologies receives approval from the European Medicines Agency for tecovirimat
10 January 2021 - Broader indication to include smallpox, monkeypox, cowpox and vaccinia complications. ...
Posted by Michael Wonder on 11 Jan 2022
4D Molecular Therapeutics announces FDA fast track designation granted to 4D-125 for the treatment of X-linked retinitis pigmentosa
10 January 2022 - 4D Molecular Therapeutics announced that the U.S. FDA has granted fast track designation for 4D-125 for treatment ...
Posted by Michael Wonder on 11 Jan 2022
Veru announces FDA grant of fast track designation for enobosarm for the treatment of androgen receptor positive, oestrogen receptor positive, human epidermal growth factor receptor 2 negative, metastatic breast cancer
10 January 2022 - Phase 3 ARTEST registration study of enobosarm in patients with androgen receptor positive, oestrogen receptor positive, human ...
Posted by Michael Wonder on 11 Jan 2022
COUR Pharmaceuticals receives FDA fast track designation for CNP-104 for the treatment of primary biliary cholangitis
10 January 2021 - COUR Pharmaceuticals today announced the U.S. FDA granted fast track designation to the Company's investigational therapy CNP-104 ...
Posted by Michael Wonder on 10 Jan 2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
Posted by Michael Wonder on 08 Jan 2022
FDA shortens interval for booster dose of Moderna COVID-19 Vaccine to five months
7 January 2022 - Today, the U.S. FDA amended the emergency use authorisation for the Moderna COVID-19 Vaccine to shorten the ...
Posted by Michael Wonder on 07 Jan 2022
AbbVie submits applications for upadacitinib (Rinvoq) in non-radiographic axial spondyloarthritis to U.S. FDA and EMA
7 January 2022 - Submissions supported by Phase 3 study in which upadacitinib (Rinvoq) demonstrated significant improvements in signs and symptoms ...
Posted by Michael Wonder on 07 Jan 2022
Dynacure receives fast track designation for DYN101, an investigational antisense oligonucleotide for the treatment of myotubular and centronuclear myopathies
6 January 2022 - Dynacure today announced that the U.S. FDA has granted fast track designation for its lead product ...
Posted by Michael Wonder on 07 Jan 2022
Otsuka and Lundbeck announce FDA approval of supplemental new drug application for Rexulti (brexpiprazole) to treat schizophrenia in paediatric patients ages 13-17
6 January 2022 - Otsuka and Lundbeck announce the U.S. FDA has approved the supplemental new drug application of Rexulti ...