Blog
RSS FeedPosted by Michael Wonder on 15 Dec 2018
Celltrion and Teva announce FDA approval of Herzuma (trastuzumab-pkrb), a biosimilar to Herceptin, for the treatment of HER2-over-expressing breast cancer for certain indications
15 December 2018 - Celltrion and Teva Pharmaceutical Industries today announced that the U.S. FDA has approved Herzuma (trastuzumab-pkrb), a ...
Posted by Michael Wonder on 15 Dec 2018
FDA approves Nplate (romiplostim) for use in paediatric patients with immune thrombocytopenia
14 December 2018 - Application granted priority review designation. ...
Posted by Michael Wonder on 12 Dec 2018
Mallinckrodt's SpecGx receives FDA complete response letter for abuse-deterrent, immediate-release reformulation of Roxicodone (oxycodone hydrochloride)
12 December 2018 - SpecGx announced today that it has received a complete response letter from the U.S. FDA related ...
Posted by Michael Wonder on 12 Dec 2018
Metastasis-free survival in prostate cancer: faster drug approvals, better drugs?
12 December 2018 - On 13 February 2018, the US FDA granted marketing authorisation to apalutamide for treatment of non-metastatic castration-resistant ...
Posted by Michael Wonder on 12 Dec 2018
Mayne Pharma receives FDA approval of Tolsura (SUBA-itraconazole capsules) for the treatment of certain fungal infections
11 December 2018 - Mayne Pharma is pleased to announce that the US FDA has approved the new drug application ...
Posted by Michael Wonder on 07 Dec 2018
FDA approves Genentech’s Tecentriq in combination with Avastin and chemotherapy for the initial treatment of people with a specific type of metastatic lung cancer
6 December 2018 - Approval based on survival benefit of Tecentriq, in combination with Avastin, paclitaxel and carboplatin (chemotherapy), in people ...
Posted by Michael Wonder on 06 Dec 2018
Federal officials call out FDA over lapses in rare-disease drug approval
5 December 2018 - The 1983 Orphan Drug Act motivated pharmaceutical companies to develop drugs for people who lacked treatments ...
Posted by Michael Wonder on 04 Dec 2018
Ocular Therapeutix announces FDA approval of Dextenza for the treatment of ocular pain following ophthalmic surgery
3 December 2018 - Dextenza (dexamethasone ophthalmic insert) is the first intra-canalicular insert for drug delivery. ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
28 November 2018 - The U.S. FDA today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in adults. ...
Posted by Michael Wonder on 29 Nov 2018
FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukaemia with a certain genetic mutation
28 November 2018 - The U.S. FDA today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed ...
Posted by Michael Wonder on 28 Nov 2018
FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma
28 November 2018 - The agency has now approved 15 biosimilars and is advancing new policies to improve the efficiency of ...
Posted by Michael Wonder on 27 Nov 2018
Perrigo announces tentative FDA approval for the first to file generic version of Ultravate lotion 0.05%
26 November 2018 - Perrigo today announced it has received tentative approval from the U.S. FDA for the first to ...
Posted by Michael Wonder on 27 Nov 2018
FDA approves the ACTpen for Genentech’s Actemra, a single-dose, pre-filled auto-injector for the treatment of rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis
26 November 2018 - Genentech announced today that the U.S. FDA has approved ACTPen 162 mg/0.9 mL, a single-dose pre-filled auto-injector ...
Posted by Michael Wonder on 26 Nov 2018
FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumour
26 November 2018 - The U.S. FDA today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and paediatric ...
Posted by Michael Wonder on 21 Nov 2018
AbbVie receives US FDA accelerated approval for Venclexta (venetoclax) for treatment of newly-diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
21 November 2018 - The approval in AML is the third provided under priority review by the U.S. FDA for Venclexta, ...