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RSS FeedPosted by Michael Wonder on 15 Jan 2019
FDA approves expanded use of Adacel (Tdap) vaccine for repeat vaccination
14 January 2019 - First and only vaccine approved in the U.S. for repeat vaccination 8 years or more after the ...
Posted by Michael Wonder on 15 Jan 2019
Exelixis announces U.S. FDA approval of Cabometyx (cabozantinib) tablets for previously treated hepatocellular carcinoma
14 January 2019 - Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 ...
Posted by Michael Wonder on 07 Jan 2019
KemPharm announces FDA approval of sNDA for two additional strengths of Apadaz (4.08 mg benzhydrocodone/325 mg APAP and 8.16 mg benzhydrocodone/325 mg APAP)
7 January 2019 - Apadaz now approved in three dosage strengths, providing greater flexibility to prescribers through additional dosing options. ...
Posted by Michael Wonder on 06 Jan 2019
Slayback Pharma announces FDA approval of hydroxyprogesterone caproate injection, USP 1,250 mg/5 mL in a multi-dose vial, the first generic equivalent of Makena injection 1,250 mg/5 mL multi-dose vial
2 January 2019 - Slayback Pharma announced today that the U.S. FDA granted approval of its abbreviated new drug application ...
Posted by Michael Wonder on 06 Jan 2019
Banner receives FDA tentative approval for Bafiertam for the treatment of relapsing forms of multiple sclerosis
2 January 2019 - Banner Life Sciences announced today that the U.S. FDA granted tentative approval on 16 November 2018 ...
Posted by Michael Wonder on 02 Jan 2019
Bristol-Myers Squibb’s Sprycel (dasatinib) tablets now approved in combination with chemotherapy in certain paediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia
2 January 2018 - Approval marks second paediatric leukaemia indication for Sprycel. ...
Posted by Michael Wonder on 02 Jan 2019
U.S. FDA approves Portola Pharmaceuticals’ prior approval supplement for Andexxa Generation 2 manufacturing process
31 December 2018 - Expands patient access to Andexxa, the first and only antidote for reversal of the Factor Xa ...
Posted by Michael Wonder on 28 Dec 2018
US FDA requests further data for VivaGel BV approval
27 December 2018 - Regulatory processes underway continue in other markets and are independent of FDA approval. ...
Posted 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 ...