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RSS FeedPosted by Michael Wonder on 10 Aug 2018
US FDA approves Arakoda (tafenoquine) tablets for oral use; first preventative antimalarial approved in almost two decades
9 August 2018 - 60 Degrees Pharmaceuticals announced today the U.S. FDA approval of Arakoda (tafenoquine) tablets for the prevention of ...
Posted by Michael Wonder on 08 Aug 2018
FDA approves treatment for two rare types of non-Hodgkin lymphoma
8 August 2018 - The U.S. FDA today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients ...
Posted by Michael Wonder on 08 Aug 2018
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
8 August 2018 - The U.S. FDA today approved several strengths of potassium chloride oral solution as the first generic drugs ...
Posted by Michael Wonder on 06 Aug 2018
Complete response letter issued for Remoxy
6 August 2018 - Pain Therapeutics today announced it had received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 01 Aug 2018
FDA approves blood disorder drug made by Japan's Shionogi
1 August 2018 - The U.S. FDA on Tuesday approved Japan-based Shionogi's treatment for low blood-platelet count or thrombocytopenia in patients ...
Posted by Michael Wonder on 31 Jul 2018
FDA approves first treatment for rare adrenal tumours
30 July 2018 - The U.S. FDA today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of ...
Posted by Michael Wonder on 29 Jul 2018
Insys Therapeutics receives complete response letter from FDA for buprenorphine NDA
27 July 2018 - Insys Therapeutics announced that today it received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 29 Jul 2018
FDA approves Perseris (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults
27 July 2018 - Perseris is the first once-monthly subcutaneous risperidone-containing long-acting injectable. ...
Posted by Michael Wonder on 24 Jul 2018
AbbVie receives U.S. FDA approval of Orilissa (elagolix) for the management of moderate to severe pain associated with endometriosis
24 July 2018 - FDA approval is supported by the largest endometriosis Phase 3 study program conducted to date. ...
Posted by Michael Wonder on 22 Jul 2018
US FDA approves Krintafel (tafenoquine) for the radical cure of P. vivax malaria
20 July 2018 - First single-dose medicine to prevent the relapse of P. vivax malaria marks a major contribution towards ...
Posted by Michael Wonder on 20 Jul 2018
U.S. FDA approves Pfizer's biosimilar Nivestym (filgrastim-aafi)
20 July 2018 - Nivestym, a biosimilar to Neupogen (filgrastim), is Pfizer's fourth biosimilar to be approved by the FDA. ...
Posted by Michael Wonder on 20 Jul 2018
FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukeamia who have a certain genetic mutation
20 July 2018 - The U.S. FDA today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or ...
Posted by Michael Wonder on 20 Jul 2018
FDA approves new indications for Zomacton (somatropin) as Ferring plans launch of needle-free delivery system
19 July 2018 - Ferring will launch ZOMA-Jet 10 needle-free delivery system for Zomacton in September. ...
Posted by Michael Wonder on 19 Jul 2018
Lilly's once-weekly Trulicity (dulaglutide) label updated to include data showing benefits for adults with type 2 diabetes and chronic kidney disease
19 July 2018 - The U.S. label for Eli Lilly's once-weekly Trulicity (dulaglutide) is updated to show the medicine's safety and ...
Posted by Michael Wonder on 18 Jul 2018
Novartis Kisqali now first and only CDK4/6 inhibitor indicated in US as first-line therapy specifically for pre-menopausal women; and as initial therapy with fulvestrant in postmenopausal women
18 July 2018 - Kisqali is now the only CDK4/6 inhibitor indicated in combination with an aromatase inhibitor as first-line treatment ...