Blog
RSS FeedPosted by Michael Wonder on 24 May 2018
FDA grants breakthrough therapy designation for tafamidis for the treatment of patients with transthyretin cardiomyopathy
23 May 2018 - Pfizer announced today that tafamidis received breakthrough therapy designation from the US FDA for the treatment ...
Posted by Michael Wonder on 23 May 2018
Sun Pharma announces USFDA approval of Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer in combination with methylprednisolone
23 May 2018 - Sun Pharma had acquired Yonsa from Churchill Pharmaceuticals and will commercialise Yonsa in the U.S. ...
Posted by Michael Wonder on 22 May 2018
Lilly's Taltz (ixekizumab) receives the first U.S. FDA approval for label update to include data for psoriasis involving the genital area
22 May 2018 - The label update is effective immediately in the United States. ...
Posted by Michael Wonder on 22 May 2018
GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma
21 May 2018 - GSK today announced it has received approval from the US FDA for the use of Arnuity Ellipta ...
Posted by Michael Wonder on 21 May 2018
FDA approves new drug for patients with chronic liver disease who have low blood platelets and are undergoing a medical procedure
21 May 2018 - The U.S. FDA today approved Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults ...
Posted by Michael Wonder on 19 May 2018
Lokelma approved in the US for the treatment of adults with hyperkalaemia
18 May 2018 - Lokelma provides a rapid and sustained treatment for hyperkalaemia, a condition with high unmet need. ...
Posted by Michael Wonder on 18 May 2018
F.D.A. approves first drug designed to prevent migraines
18 May 2018 - The first medicine designed to prevent migraines was approved by the FDA on Thursday, ushering in ...
Posted by Michael Wonder on 17 May 2018
FDA approves Aimovig (erenumab-aooe), a novel treatment developed specifically for migraine prevention
17 May 2018 - Aimovig is the first and only FDA approved treatment to block the calcitonin gene-related peptide receptor, which ...
Posted by Michael Wonder on 17 May 2018
FDA faster than global peers at approving new drugs
16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...
Posted by Michael Wonder on 17 May 2018
FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
16 May 2018 - Encouraging more widespread innovation and development of safe and effective treatments for opioid use disorder remains top ...
Posted by Michael Wonder on 16 May 2018
U.S. FDA approves expanded indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for reducing the risk of acquiring HIV-1 in adolescents
15 May 2018 - First agent indicated for uninfected adolescents at risk of acquiring HIV. ...
Posted by Michael Wonder on 15 May 2018
FDA approves first epoetin alfa biosimilar for the treatment of anemia
15 May 2017 - The U.S. Food and Drug Administration today approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen/Procrit (epoetin ...
Posted by Michael Wonder on 15 May 2018
FDA approves subcutaneous formulation of Actemra for use in active polyarticular juvenile idiopathic arthritis, a rare form of juvenile arthritis
14 May 2018 - Genentech announced today that the U.S. FDA has approved the subcutaneous formulation of Actemra (tocilizumab) for the ...
Posted by Michael Wonder on 15 May 2018
UCB announces Briviact (brivaracetam) now approved by FDA to treat partial-onset (focal) seizures in paediatric epilepsy patients
14 May 2018 - Indication comes less than 2 years after the launch of Briviact in the U.S., building on existing ...
Posted by Michael Wonder on 13 May 2018
Perrigo expects complete response letter on generic version of ProAir
11 May 2018 - Perrigo today announced that it expects to receive a complete response letter from the U.S. FDA regarding ...