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RSS FeedPosted by Michael Wonder on 26 Oct 2020
Santen announces U.S. FDA filing acceptance of new drug application for cyclosporin 0.1% topical ophthalmic emulsion for the treatment of severe vernal keratoconjunctivitis in patients ages 4-18
26 October 2020 - Santen today announced that the U.S. FDA has accepted the new drug application for cyclosporin 0.1% topical ...
Posted by Michael Wonder on 26 Oct 2020
Forte Biosciences announces the FDA has granted fast track designation to FB-401 for the treatment of atopic dermatitis
26 October 2020 - Forte Biosciences today announced that the U.S. FDA has granted fast track designation to FB-401 for the ...
Posted by Michael Wonder on 26 Oct 2020
Janssen submits application to U.S. FDA for new indication to expand use of Xarelto (rivaroxaban) in patients with peripheral artery disease
26 October 2020 - Application seeks approval of Xarelto plus aspirin to reduce the risk of major thrombotic vascular events in ...
Posted by Michael Wonder on 26 Oct 2020
Spectrum Pharmaceuticals announces that the FDA is deferring its action on the BLA for Rolontis (eflapegrastim)
26 October 2020 - Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel ...
Posted by Michael Wonder on 26 Oct 2020
European Union would apply lower threshold in assessing COVID-19 vaccine
25 October 2020 - The EU’s drug regulator is willing to approve a vaccine even if it were effective in less ...
Posted by Michael Wonder on 24 Oct 2020
FDA approves FoundationOneCDx as companion diagnostic for Vitrakvi (larotrectinib) to aid in identifying NTRK fusion positive patients
23 October 2020 - Detection of genomic alterations that drive the growth and spread of the tumour can guide treatment decisions ...
Posted by Michael Wonder on 24 Oct 2020
FDA shows signs of cold feet over emergency authorisation of COVID-19 vaccines
23 October 2020 - There are serious signs the FDA is getting cold feet over the notion of issuing emergency ...
Posted by Michael Wonder on 24 Oct 2020
Medicago signs agreements with the Government of Canada to supply up to 76 million doses of its recombinant plant-derived COVID-19 vaccine
23 October 2020 - Canadian government to provide $173M in funding for vaccine research and development, and domestic manufacturing capacity. ...
Posted by Michael Wonder on 23 Oct 2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies
23 October 2020 - Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate ...
Posted by Michael Wonder on 22 Oct 2020
FDA approves first treatment for COVID-19
22 October 2020 - Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult ...
Posted by Michael Wonder on 22 Oct 2020
Oxford developed COVID-19 vaccine, then scholars clashed over money
21 October 2020 - Early deal with Merck was scotched for fear poor countries would be left out; now university could ...
Posted by Michael Wonder on 22 Oct 2020
Remdesivir’s hefty price tag ignores NIH investment in its creation
22 October 2020 - Throughout the Democratic presidential primary, candidates cast a spotlight on the broken U.S. health care system ...
Posted by Michael Wonder on 22 Oct 2020
Leo Pharma announces U.S. FDA approval for Enstilar (calcipotriene and betamethasone dipropionate) foam U.S. Prescribing Information update to include data in long-term use in plaque psoriasis treatment
22 October 2020 - U.S. Prescribing Information updated to include PSO-LONG clinical trial data concerning long-term use (52 weeks) of twice-weekly ...
Posted by Michael Wonder on 22 Oct 2020
F2G receives second US FDA breakthrough therapy designation for Olorofim
22 October 2020 - In Phase 2b development for the treatment of life-threatening fungal infections. ...
Posted by Michael Wonder on 22 Oct 2020
AppliedVR receives FDA breakthrough device designation to treat pain with digital therapeutic
21 October 2020 - AppliedVR today announced its EaseVRx product received breakthrough device designation from the U.S. FDA for treating ...