Blog
RSS FeedPosted by Michael Wonder on 27 May 2016
Cancer drugs are the least likely to receive FDA approval
26 May 2016 - But there’s good reason to hope that may change very soon. ...
Posted by Michael Wonder on 27 May 2016
Muscular dystrophy day at the FDA
25 May 2016 - The agency again delays a decision on a therapy for a deadly disease. ...
Posted by Michael Wonder on 26 May 2016
FDA approves first buprenorphine implant for treatment of opioid dependence
26 May 2016 - Expanded use and availability of medication-assisted treatment is a top priority of federal effort to combat opioid ...
Posted by Michael Wonder on 26 May 2016
FDA approval of Afstyla (rFVIII-single chain)
26 May 2016 - CSL today announced that the US FDA has approved Afstyla [anti-haemophilic factor (recombinant), single chain], CSL Behring’s ...
Posted by Michael Wonder on 25 May 2016
FDA expands indication of Invokamet (canagliflozin/metformin HCl) to include first-line treatment of adults with type 2 diabetes
24 May 2016 - Janssen Pharmaceuticals today announced the U.S. FDA has approved Invokamet, a fixed-dose combination therapy of Invokana (canagliflozin) ...
Posted by Michael Wonder on 24 May 2016
FDA approves CSL's Flucelvax quadrivalent influenza vaccine
24 May 2016 - CSL today announced that the US FDA has approved Seqirus’ Flucelvax Quadrivalent (Influenza Vaccine), the first four-strain, ...
Posted by Michael Wonder on 24 May 2016
Patient reported outcomes labeling for products approved by the Office of Hematology and Oncology Products of the US FDA (2010-2014)
23 May 2016 - Ari Gnanasakathy et al. have reviewed the use of patient-reported outcome (PRO) data in medical product labeling ...
Posted by Michael Wonder on 24 May 2016
Samsung targets US drug market with Remicade knockoff
24 May 2016 - Affiliate Samsung Bioepis says its biosimilar of the arthritis drug is being reviewed by the FDA. ...
Posted by Michael Wonder on 20 May 2016
Celator Pharmaceuticals announces Vyxeos granted breakthrough therapy designation
19 May 2016 - Celator Pharmaceuticals today announced that the US FDA granted breakthrough therapy designation to Vyxeos (also known as ...
Posted by Michael Wonder on 20 May 2016
Poliovirus therapy against cancer given ‘breakthrough’ status by FDA
17 May 2016 - FDA decision will fast-track research on breakthrough Duke brain cancer therapy. ...
Posted by Michael Wonder on 19 May 2016
FDA approves an immunotherapy drug for bladder cancer
19 May 2016 - The FDA on Wednesday approved a new immunotherapy drug from Roche to treat bladder cancer, a form ...
Posted by Michael Wonder on 18 May 2016
Novo Nordisk files for regulatory approval in the US of long-acting factor IX for the treatment of haemophilia B
16 May 2016 - Novo Nordisk today announced the submission to the US FDA of the Biologics License Application for the ...
Posted by Michael Wonder on 18 May 2016
FDA approves new, targeted treatment for bladder cancer
18 May 2016 - Tecentriq is the first PD-L1 inhibitor approved by the FDA. ...
Posted by Michael Wonder on 18 May 2016
Opdivo (nivolumab) granted first approval of a PD-1 inhibitor in haematology for the treatment of classical Hodgkin's lymphoma patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin by the FDA
17 May 2016 - Bristol-Myers Squibb today announced the U.S. FDA has approved Opdivo (nivolumab) for the treatment of patients with ...
Posted by Michael Wonder on 18 May 2016
Biofrontera announces U.S. FDA approval of Ameluz and activating BF-RhodoLED device for treatment of actinic keratosis
11 May 2016 - Biofrontera today announced that the U.S. FDA has granted approval of its combination topical prescription drug Ameluz ...