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RSS FeedPosted by Michael Wonder on 07 Jun 2017
Calithera Biosciences announces FDA fast track designation granted to CB-839 for treatment of patients with renal cell carcinoma
Calithera Biosciences today announced that the U.S. FDA has granted fast track designation to CB-839 in combination with everolimus, for ...
Posted by Michael Wonder on 07 Jun 2017
FDA approves two month Aristada for treatment of schizophrenia
6 June 2017 - Approval expands Aristada's product offerings to Include once monthly, once every six weeks and once every ...
Posted by Michael Wonder on 07 Jun 2017
Pfizer receives FDA fast track designation for tafimidis for transthyretin cardiomyopathy
6 June 2017 - Tafamidis, an investigational medicine for TTR-CM a rare, progressive and fatal disease, is currently in phase ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...
Posted by Michael Wonder on 06 Jun 2017
Drug prices become target for FDA as chief expands purview
6 June 2017 - Commissioner would prioritise additional competing generics. ...
Posted by Michael Wonder on 06 Jun 2017
The value of using registries to evaluate randomised clinical trial study populations
5 June 2017 - Randomised clinical trials are considered the gold standard of medical research and influence clinical practice, but they ...
Posted by Michael Wonder on 06 Jun 2017
BioCryst announces Rapivab paediatric sNDA acceptance
5 June 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has accepted for review the supplemental new drug ...
Posted by Michael Wonder on 06 Jun 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) + Yervoy (ipilimumab) regimen receives expanded FDA approval in unresectable or metastatic melanoma across BRAF status
23 January 2016 - Opdivo + Yervoy regimen now indicated for unresectable or metastatic melanoma patients, regardless of BRAF mutational status, ...
Posted by Michael Wonder on 06 Jun 2017
Bristol-Myers Squibb’s Opdivo (nivolumab) is the first immuno-oncology treatment to receive FDA approval based on overall survival in head and neck cancer
10 November 2016 - Opdivo is the first and only immuno-oncology treatment proven in a Phase 3 trial to significantly extend ...
Posted by Michael Wonder on 06 Jun 2017
Bayer receives FDA approval of myBETAapp and BETACONNECT Navigator
30 May 2017 - Now-approved combination of medicine, device, mobile and cloud-based health technology. ...
Posted by Michael Wonder on 05 Jun 2017
Genmab announces U.S. FDA approval of Arzerra (ofatumumab) as extended treatment for recurrent or progressive CLL
19 January 2016 - Arzerra previously approved to treat previously untreated and refractory chronic lymphocytic leukaemia indications in the US. ...
Posted by Michael Wonder on 05 Jun 2017
Amgen submits regulatory applications for Repatha (evolocumab) cardiovascular outcomes data in US and Europe
5 June 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA and a ...
Posted by Michael Wonder on 05 Jun 2017
FDA expands use of Sapien 3 artificial heart valve for high-risk patients
5 June 2017 - Expanded use approval relies on real world evidence. ...
Posted by Michael Wonder on 04 Jun 2017
ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months. ...
Posted by Michael Wonder on 04 Jun 2017
Merck receives accelerated approval of Keytruda (pembrolizumab), the first FDA approved anti-PD-1 therapy
4 September 2014 - Merck today announced that the US FDA has approved Keytruda (pembrolizumab) at a dose of 2 ...