Blog
RSS FeedPosted by Michael Wonder on 28 Dec 2018
Horizon Pharma announces FDA approval to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to include newborns
27 December 2018 - Horizon Pharma today announced the U.S. FDA has approved a supplemental new drug application to expand the ...
Posted by Michael Wonder on 27 Dec 2018
FDA approves Vaxelis, Sanofi and MSD’s paediatric hexavalent combination vaccine
26 December 2018 - The U.S. FDA has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, ...
Posted by Michael Wonder on 24 Dec 2018
Braeburn announces tentative FDA approval of Brixadi (buprenorphine) extended-release injection for the treatment of moderate to severe opioid use disorder
23 December 2018 - Brixadi is a long-acting buprenorphine injectable with both weekly and monthly doses to align with the way ...
Posted by Michael Wonder on 23 Dec 2018
Acorda Therapeutics announces FDA approval of Inbrija (levodopa inhalation powder)
21 December 2018 - Expected to be available by prescription in first quarter 2019. ...
Posted by Michael Wonder on 21 Dec 2018
FDA approves new treatment for adult patients with rare, life-threatening blood disease
21 December 2018 - The U.S. FDA today approved Ultomiris (ravulizumab) injection for the treatment of adult patients with paroxysmal nocturnal ...
Posted by Michael Wonder on 21 Dec 2018
FDA approves first treatment for rare blood disease
21 December 2018 - The U.S. FDA today approved Elzonris (tagraxofusp-erzs) infusion for the treatment of blastic plasmacytoid dendritic cell neoplasm ...
Posted by Michael Wonder on 20 Dec 2018
FDA approves new indication for Envarsus XR (tacrolimus extended-release tablets)
19 December 2018 - Veloxis Pharmaceuticals announced today that the U.S. FDA approved a new indication for Envarsus XR (tacrolimus ...
Posted by Michael Wonder on 20 Dec 2018
FDA approves Merck’s Keytruda (pembrolizumab) for the treatment of adult and paediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma, a rare form of skin cancer
19 December 2018 - Accelerated approval based on results of CITN-09/KEYNOTE-017, where Keytruda monotherapy demonstrated an objective response rate of 56%. ...
Posted by Michael Wonder on 19 Dec 2018
Lynparza approved by US FDA for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer
19 December 2018 - AstraZeneca and MSD’s Lynparza reduced the risk of disease progression or death by 70% compared to placebo ...
Posted by Michael Wonder on 18 Dec 2018
FDA approves Shire’s Motegrity (prucalopride), the only serotonin-4 receptor agonist for adults with chronic idiopathic constipation
17 December 2018 - Unlike other prescription chronic idiopathic constipation treatments, Motegrity works differently by enhancing natural movements of the colon ...
Posted by Michael Wonder on 15 Dec 2018
Supernus announces FDA approval of sNDA to expand Oxtellar XR label to include monotherapy
14 December 2018 - Supernus Pharmaceuticals announced today that the United States FDA has approved the Company’s supplemental new drug ...
Posted 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 ...