Blog
RSS FeedPosted by Michael Wonder on 07 Aug 2018
Array Biopharma receives FDA breakthrough therapy designation for Braftovi in combination with Mektovi and cetuximab for BRAF V600E mutant metastatic colorectal cancer
7 August 2018 - Designation based on Phase 3 BEACON CRC safety lead-in data. ...
Posted by Michael Wonder on 06 Aug 2018
Karyopharm completes rolling submission of new drug application to U.S. FDA for selinexor as a treatment for patients with penta-refractory multiple myeloma
6 August 2018 - Selinexor has received both orphan drug and fast track designations from the FDA for this indication. ...
Posted by Michael Wonder on 06 Aug 2018
FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder
6 August 2018 - The U.S. FDA today issued new scientific recommendations aimed at encouraging more widespread innovation and development of ...
Posted by Michael Wonder on 06 Aug 2018
Complete response letter issued for Remoxy
6 August 2018 - Pain Therapeutics today announced it had received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 06 Aug 2018
U.S. FDA grants fast track designation for BioCryst’s BCX7353
6 August 2018 - BioCryst Pharmaceuticals today announced that the Company has been granted fast track designation by the U.S. ...
Posted by Michael Wonder on 04 Aug 2018
Statement from FDA Commissioner Scott Gottlieb on new steps the agency is taking to support the development of novel nicotine replacement drug therapies to help smokers quit cigarettes
3 August 2018 - As a public health agency, there is no greater impact we can have to improve the ...
Posted by Michael Wonder on 02 Aug 2018
Evolus announces early resubmission to the FDA of its biologics licence application for DWP-450
2 August 2018 - Commercial launch planned for spring 2019. ...
Posted by Michael Wonder on 02 Aug 2018
Acrux submits first-to-file application for generic version of Jublia making it eligible for 180 days of generic exclusivity
2 August 2018 - Acrux is pleased to announce that the US FDA has accepted for review the Paragraph IV Abbreviated ...
Posted by Michael Wonder on 02 Aug 2018
FDA and EMA to hold workshop on breakthrough therapy and PRIME designations
2 August 2018 - The US FDA and EMA will hold a workshop on early access approaches, including PRIME and ...
Posted by Michael Wonder on 01 Aug 2018
FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development
1 August 2018 - We know that novel manufacturing technologies for both small-molecule drugs and biological products have great potential to ...
Posted by Michael Wonder on 01 Aug 2018
FDA approves blood disorder drug made by Japan's Shionogi
1 August 2018 - The U.S. FDA on Tuesday approved Japan-based Shionogi's treatment for low blood-platelet count or thrombocytopenia in patients ...
Posted by Michael Wonder on 01 Aug 2018
FDA grants breakthrough therapy designation to Daiichi Sankyo’s FLT3 inhibitor quizartinib for relapsed/refractory FLT3-ITD AML
1 August 2018 - Third breakthrough therapy designation granted by FDA for a compound in the oncology pipeline of Daiichi ...
Posted by Michael Wonder on 01 Aug 2018
Eisai and Merck announce FDA grants breakthrough therapy designation for Lenvima (lenvatinib) in combination with Keytruda (pembrolizumab) as therapy for previously treated patients with advanced and/or metastatic non-MSI-H/pMMR endometrial carcinoma
31 July 2018 - Eisai and Merck announced today that the U.S. FDA granted breakthrough therapy designation for Lenvima (lenvatinib), the ...
Posted by Michael Wonder on 31 Jul 2018
Soleno Therapeutics receives fast track designation from FDA for DCCR for treatment of Prader-Willi syndrome
30 July 2018 - Phase III clinical trial ongoing at multiple sites in the U.S. ...
Posted by Michael Wonder on 31 Jul 2018
Nektar Therapeutics announces new drug application for NKTR-181 accepted for review by FDA
30 July 2018 - NKTR-181 is a first-in-class investigational opioid to treat chronic low back pain in adult patients new to ...