Blog
RSS FeedPosted by Michael Wonder on 12 Jul 2017
FDA grants full approval for Blincyto (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in adults and children
11 July 2017 - Data from the phase 3 TOWER study support conversion from accelerated to full approval. ...
Posted by Michael Wonder on 11 Jul 2017
Two recent scientific advances underscore an encouraging future for precision medicine at FDA
11 July 2017 - FDA helps bring precision medicine – in the form of targeted therapies — to people living ...
Posted by Michael Wonder on 11 Jul 2017
FDA speeding generic drug approvals: not just lip service
10 July 2017 - May and June 2017 have seen the most generic drug approvals since the US FDA began ...
Posted by Michael Wonder on 10 Jul 2017
U.S. FDA accepts for priority review Bristol-Myers Squibb’s application for Sprycel (dasatinib) in children with Philadelphia chromosome positive chronic phase chronic myeloid leukaemia
10 July 2017 - Application is based on results from Phase 2 CA180-226 study. ...
Posted by Michael Wonder on 10 Jul 2017
FDA grants priority review for Lilly's abemaciclib for the treatment of advanced breast cancer
10 July 2017 - Eli Lilly and Company (NYSE: LLY) today announced that the U.S. FDA has accepted and filed its ...
Posted by Michael Wonder on 08 Jul 2017
Endo gives in to FDA demand and agrees to yank its opioid painkiller
7 July 2017 - In the end, the executive team at Endo International blinked. ...
Posted by Michael Wonder on 08 Jul 2017
FDA approves new treatment for sickle cell disease
7 July 2017 - The U.S. FDA today approved Endari (L-glutamine oral powder) for patients age five years and older ...
Posted by Michael Wonder on 06 Jul 2017
Bristol-Myers Squibb’s Orencia (abatacept) receives FDA approval for treatment of active psoriatic arthritis in adults
6 July 2017 - Orencia demonstrated symptom improvement in two randomised, double-blind, placebo-controlled trials that included adult patients with psoriatic arthritis ...
Posted by Michael Wonder on 05 Jul 2017
Home-to-home time — measuring what matters to patients and payers
5 July 2017 - Length of hospital stay is no longer an accurate reflection of the patient’s experience of an episode ...
Posted by Michael Wonder on 05 Jul 2017
Cardiome' partner SteadyMed submits U.S. new drug application for Trevyent for the treatment of pulmonary arterial hypertension
3 July 2017 - Cardiome Pharma Corporation today announced that partner SteadyMed submitted a new drug application to the U.S. FDA ...
Posted by Michael Wonder on 04 Jul 2017
Are drug regulators really too slow?
29 June 2017 - Regulators are often accused of delaying approval of new drugs by slow processes. Tom Marciniak and ...
Posted by Michael Wonder on 04 Jul 2017
Amphora (L-lactic acid, citric acid, and potassium bitartrate) receives QIDP designation from the FDA
29 June 2017 - Designation includes two separate indications and provides eligibility for priority review and additional exclusivity. ...
Posted by Michael Wonder on 03 Jul 2017
EMA and FDA encourage use of innovative approaches in the development of medicines for Gaucher disease
3 July 2017 - Approach aims to facilitate development of medicines for rare paediatric diseases in general. ...
Posted by Michael Wonder on 02 Jul 2017
Fears over a medical gold rush in cancer drug race
3 July 2017 - With almost 800 trials under way observers warn scientific rigour is being compromised. ...
Posted by Michael Wonder on 02 Jul 2017
Astellas submits supplemental new drug application for mirabegron for use in combination with solifenacin succinate 5 mg for the treatment of overactive bladder
30 June 2017 - Astellas announced today the submission of a supplemental new drug application to the U.S. FDA seeking approval ...