Blog
RSS FeedPosted by Michael Wonder on 04 Jul 2019
Grifols announces FDA approval of Xembify, 20% subcutaneous immunoglobulin for primary immunodeficiencies
4 July 2019 - Xembify is Grifols’ first 20% subcutaneous immunoglobulin for the treatment of primary immunodeficiencies. ...
Posted by Michael Wonder on 03 Jul 2019
FDA approves new treatment for refractory multiple myeloma
3 July 2019 - Today, the U.S. FDA granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone ...
Posted by Michael Wonder on 01 Jul 2019
Retrophin announces FDA approval of Thiola EC (tiopronin) 100 mg and 300 mg tablets for the treatment of cystinuria
28 June 2019 - Enteric-coated formulation offers flexible dosing options, including administration with or without food. ...
Posted by Michael Wonder on 29 Jun 2019
Pfizer receives U.S. FDA approval for its first biosimilar, Zirabev (bevacizumab-bvzr)
28 June 2019 - Pfizer today announced the U.S. FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the ...
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
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 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
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
Ipsen announces U.S. FDA approval for newly designed pre-filled syringe for Somatuline Depot (lanreotide)
24 June 2019 - New syringe designed to help enhance injection experience. ...
Posted by Michael Wonder on 24 Jun 2019
The FDA erred in approving new women’s libido drug; don’t reward Palatin Technologies
24 June 2019 - The FDA made a mistake Friday by approving a new drug called Vyleesi for women with ...
Posted by Michael Wonder on 23 Jun 2019
FDA issues complete response letter for Ryaltris (olopatadine hydrochloride and mometasone furoate)
22 June 2019 - We would like to inform you that the U.S. FDA has issued a complete response letter ...
Posted by Michael Wonder on 22 Jun 2019
FDA declines to approve Daiichi Sankyo's blood cancer treatment
21 June 2019 - Japan’s Daiichi Sankyo Co said on Friday the U.S. FDA has declined to approve its drug ...
Posted by Michael Wonder on 22 Jun 2019
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone intracanalicular insert for ophthalmic use) for the treatment of ocular inflammation following ophthalmic surgery
21 June 2019 - Dextenza now approved for the treatment of ocular inflammation and pain following ophthalmic surgery. ...
Posted by Michael Wonder on 22 Jun 2019
Should the FDA speed up or slow down approval of new cancer drugs?
21 June 2019 - Earlier this month, the FDA announced the creation of Project Facilitate. ...