Blog
RSS FeedPosted by Michael Wonder on 02 May 2019
First FDA approved vaccine for the prevention of dengue disease in endemic regions
1 May 2019 - The U.S. FDA announced today the approval of Dengvaxia, the first vaccine approved for the prevention of ...
Posted by Michael Wonder on 01 May 2019
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as six months of age
30 April 2019 - Safety data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages six to <12 ...
Posted by Michael Wonder on 01 May 2019
Nabriva Therapeutics receives complete response letter from FDA on NDA for intravenous Contepo (fosfomycin) for injection
30 April 2019 - Issues related to facility inspections and manufacturing deficiencies at one contract manufacturer. ...
Posted by Michael Wonder on 01 May 2019
FDA approves first treatment for all genotypes of hepatitis C in paediatric patients
30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of ...
Posted by Michael Wonder on 29 Apr 2019
FDA approves device to help increase access to more lungs for transplant
26 April 2019 - The U.S. FDA today approved a device, called Xvivo Perfusion System with Steen Solution Perfusate, that can ...
Posted by Michael Wonder on 28 Apr 2019
FDA approves Samsung Bioepis' etanercept biosimilar, Eticovo
26 April 2019 - The FDA has approved Samsung Bioepis’ etanercept biosimilar, SB4, as Eticovo (etanercept-ykro). ...
Posted by Michael Wonder on 28 Apr 2019
FDA approves Praluent (alirocumab) to prevent heart attack, stroke and unstable angina requiring hospitalisation
26 April 2019 - Praluent is the first PCSK9 inhibitor that has shown a meaningful reduction in death from any cause. ...
Posted by Michael Wonder on 27 Apr 2019
FDA approves first treatment for paediatric patients with lupus
26 April 2019 - The U.S. FDA today approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus ...
Posted by Michael Wonder on 25 Apr 2019
FDA approves Bausch Health's Duobrii (halobetasol propionate and tazarotene) lotion 0.01%/0.045% for plaque psoriasis in adults
25 April 2019 - First and only topical lotion combining halobetasol propionate and tazarotene in one formulation. ...
Posted by Michael Wonder on 24 Apr 2019
AbbVie expands immunology portfolio in the U.S. with FDA approval of Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis
23 April 2019 - AbbVie today announced that the U.S. FDA approved Skyrizi (risankizumab-rzaa), an interleukin-23 inhibitor, for the treatment of ...
Posted by Michael Wonder on 23 Apr 2019
FDA permits marketing of first medical device for treatment of ADHD
19 April 2019 - The U.S. FDA today permitted marketing of the first medical device to treat attention deficit hyperactivity disorder. ...
Posted by Michael Wonder on 23 Apr 2019
FDA approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
22 April 2019 - Approval based on results of KEYNOTE-426, where Keytruda in combination with axitinib reduced the risk of death ...
Posted by Michael Wonder on 23 Apr 2019
US FDA approves Duaklir Pressair (aclidinium/formoterol) for patients with chronic obstructive pulmonary disease
17 April 2019 - Only twice-daily LAMA /LABA in the United States with COPD exacerbation data included in its prescribing information. ...
Posted by Michael Wonder on 20 Apr 2019
FDA approves first generic naloxone nasal spray to treat opioid overdose
19 April 2019 - Agency is also taking new steps to support development of over-the-counter and additional generics of naloxone to ...
Posted by Michael Wonder on 15 Apr 2019
FDA approves PureTech’s obesity device Plenity
15 April 2019 - The FDA has approved PureTech Health’s ‘space occupying’ device Plenity as a new prescription treatment for ...