Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 31 Jul 2018
FDA accepts file for cladribine tablets as potential treatment for relapsing forms of multiple sclerosis
30 July 2018 - Cladribine tablets is approved as Mavenclad in 38 countries. ...
Posted by Michael Wonder on 31 Jul 2018
FDA approves first treatment for rare adrenal tumours
30 July 2018 - The U.S. FDA today approved Azedra (iobenguane I 131) injection for intravenous use for the treatment of ...
Posted by Michael Wonder on 29 Jul 2018
Ultragenyx announces first patient dosed in Phase 1/2 study of DTX401, a gene therapy for the treatment of glycogen storage disease Type Ia; FDA grants fast track designation to gene therapy program
26 July 2018 - Ultragenyx today announced that the first patient has been dosed in the Phase 1/2 study of DTX401, ...
Posted by Michael Wonder on 29 Jul 2018
Insys Therapeutics receives complete response letter from FDA for buprenorphine NDA
27 July 2018 - Insys Therapeutics announced that today it received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 29 Jul 2018
FDA approves Perseris (risperidone) for extended-release injectable suspension for the treatment of schizophrenia in adults
27 July 2018 - Perseris is the first once-monthly subcutaneous risperidone-containing long-acting injectable. ...
Posted by Michael Wonder on 27 Jul 2018
ADMA Biologics receives PDUFA date for Bivigam regulatory submission
26 July 2018 - Prior approval supplement to amend the biologics license application for Bivigam is supported by data and documentation ...
Posted by Michael Wonder on 26 Jul 2018
Assembly Biosciences announces FDA fast track designation granted to ABI-H0731 for the treatment of hepatitis B virus infection
25 July 2018 - Assembly Biosciences today announced that the U.S. FDA has granted fast track designation to ABI-H0731 for the ...
Posted by Michael Wonder on 26 Jul 2018
FDA announces two initiatives to modernise drug quality programs
26 July 2018 - Patients expect and deserve high-quality drugs – this means consistently safe and effective medicines, free of defects ...