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RSS FeedPosted by Michael Wonder on 27 Oct 2020
Prevail Therapeutics receives U.S. FDA fast track designation for PR001 for the treatment of neuronopathic Gaucher disease
27 October 2020 - Prevail Therapeutics today announced that the U.S. FDA has granted fast track designation for the Company’s ...
Posted by Michael Wonder on 27 Oct 2020
FDA grants priority review and EMA accepts regulatory submission for Pfizer's abrocitinib, an oral once daily JAK1 inhibitor, for patients 12 and up with moderate to severe atopic dermatitis
27 October 2020 - Filings based on robust abrocitinib clinical trial data demonstrating significant symptom improvement versus placebo as well as ...
Posted 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 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 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 ...
Posted by Michael Wonder on 21 Oct 2020
FDA approves fewer generics in FY2020, ending record streak
21 October 2020 - After four straight years of posting record numbers of abbreviated new drug application approvals, the US ...