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RSS FeedPosted by Michael Wonder on 28 Jun 2019
Arrowhead Pharmaceuticals receives fast track designation for ARO-AAT for treatment of alfa-1 liver disease
27 June 2019 - Arrowhead Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to ARO-AAT, the company’s ...
Posted by Michael Wonder on 28 Jun 2019
Janssen announces U.S. FDA approval of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant ineligible
27 June 2019 - Combination regimen reduced the risk of disease progression or death by 44% in newly diagnosed patients who ...
Posted by Michael Wonder on 27 Jun 2019
Dova Pharmaceuticals announces FDA approval of supplemental new drug application for Doptelet (avatrombopag) for treatment of chronic immune thrombocytopenia
27 June 2019 - Company strengthens thrombocytopenia portfolio with ITP approval and expanded partnership with Salix for chronic liver disease indication. ...
Posted by Michael Wonder on 27 Jun 2019
Pfizer names former FDA Chief Gottlieb to Board of Directors
28 June 2019 - Scott Gottlieb, who stepped down as the chief of the U.S. FDA earlier this year, is ...
Posted by Michael Wonder on 27 Jun 2019
FDA approves first treatment for neuromyelitis optica spectrum disorder, a rare auto-immune disease of the central nervous system
27 June 2019 - The U.S. FDA today approved Soliris (eculizumab) injection for intravenous use for the treatment of neuromyelitis optica ...
Posted by Michael Wonder on 27 Jun 2019
FDA takes new step to help advance the transition of certain biological products
27 June 2019 - Today the U.S. FDA issued a proposed rule to amend its regulations on the use of master ...
Posted by Michael Wonder on 27 Jun 2019
FDA takes steps to spark development of heart failure drugs
27 June 2019 - The draft guidance, Treatment for Heart Failure: Endpoints for Drug Development, when finalised, will describe the agency’s ...
Posted by Michael Wonder on 26 Jun 2019
Real world evidence: the future is here
26 June 2019 - Use of real-world evidence is becoming increasingly common to aid the clinical development process and provide ...
Posted by Michael Wonder on 26 Jun 2019
Novartis wins Gilenya reprieve as judge blocks generics, for now
25 June 2019 - Novartis has won a U.S. federal court order preventing rival generic makers from selling versions of the ...
Posted by Michael Wonder on 26 Jun 2019
FDA seeks public feedback on new drug approval transparency efforts
26 June 2019 - Today the U.S. FDA issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package ...
Posted by Michael Wonder on 26 Jun 2019
FDA approves first treatment for chronic rhinosinusitis with nasal polyps
26 June 2019 - The U.S. FDA today approved Dupixent (dupilumab) to treat adults with nasal polyps (growths on the inner ...
Posted by Michael Wonder on 26 Jun 2019
U.S. FDA grants fast track designation to empagliflozin for the treatment of chronic heart failure
26 June 2019 - FDA's Fast Track designation for empagliflozin underscores the urgent need for new potential treatment options for the ...
Posted by Michael Wonder on 26 Jun 2019
Forward into the past with FDA’s new history exhibit
25 June 2019 - From the “Poison Squad” to AIDS activism, the FDA’s new history exhibit brings the Agency’s past to ...
Posted by Michael Wonder on 26 Jun 2019
Acer Therapeutics receives complete response letter from U.S. FDA for use of Edsivo (celiprolol) in vEDS patients
25 June 2019 - Acer Therapeutics today announced it has received a complete response letter from the U.S. FDA regarding its ...
Posted by Michael Wonder on 25 Jun 2019
U.S. FDA accepts GSK’s application for Zejula (niraparib) in late stage ovarian cancer with priority review
24 June 2019 - GlaxoSmithKline plc today announced that Tesaro, an oncology-focused business acquired by GSK, submitted a supplemental new ...