Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 May 2016
U.S. FDA approves additional indication for Eisai's anti-cancer agent Lenvima in combination with everolimus as treatment for advanced renal cell carcinoma
16 May 2016 - Eisai announced today that its U.S. subsidiary Eisai Inc. has received approval from the U.S. FDA ...
Posted by Michael Wonder on 10 May 2016
FDA’s foray into big data still maturing
10 May 2016 - With access to claims data on about 200 million patients and 5.5 billion patient encounters across the ...
Posted by Michael Wonder on 10 May 2016
U.S. FDA expands Imbruvica (ibrutinib) label to include overall survival data in previously untreated chronic lymphocytic leukaemia and new indication for small lymphocytic lymphoma patients
9 May 2016 - AbbVie today announced the U.S. FDA updated the Imbruvica (ibrutinib) Prescribing Information to include new data from ...
Posted by Michael Wonder on 05 May 2016
FDA grants priority review for Lilly's olaratumab, an investigational medicine for advanced soft tissue sarcoma
4 May 2016 - Eli Lilly announced today that the U.S. FDA has granted priority review for the biologics license application ...
Posted by Michael Wonder on 04 May 2016
FDA grants priority review for Amgen's supplemental biologics license application for Blincyto (blinatumomab)
3 May 2016 - Amgen today announced that the US FDA has accepted for priority review the supplemental biologics license application ...
Posted by Michael Wonder on 03 May 2016
Eisai announces FDA approval of Fycompa (perampanel) oral suspension for adjunctive therapy in the treatment of partial-onset seizures and primary generalized tonic-clonic seizures
2 May 2016 - Eisai Inc. today announced that the U.S. FDA has approved Fycompa (perampanel) oral suspension as adjunctive therapy ...
Posted by Michael Wonder on 03 May 2016
Flamel Technologies receives FDA approval of Akovaz
2 May 2016 - Flamel Technologies today announced that the U.S. FDA has approved the Company’s new drug application for ...