Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 26 Jul 2018
Drug companies can’t game paediatric drug laws anymore
26 July 2018 - Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally ...
Posted by Michael Wonder on 25 Jul 2018
FDA publishes list of surrogate outcomes used in drug approvals
25 July 2018 - The US FDA on Wednesday published a list of surrogate outcomes to help inform drug developer ...
Posted by Michael Wonder on 25 Jul 2018
Scientist invented a new pathway to approve biosimilars, and the FDA is listening
25 July 2018 - In an extraordinary move, the FDA has withdrawn the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity,” ...
Posted by Michael Wonder on 24 Jul 2018
Apellis Pharmaceuticals’ APL-2 receives fast track designation from FDA for the treatment of patients with geographic atrophy
24 July 2018 - Apellis Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to the Company’s ...
Posted by Michael Wonder on 24 Jul 2018
AbbVie receives U.S. FDA approval of Orilissa (elagolix) for the management of moderate to severe pain associated with endometriosis
24 July 2018 - FDA approval is supported by the largest endometriosis Phase 3 study program conducted to date. ...
Posted by Michael Wonder on 23 Jul 2018
Allergan receives FDA fast track designation for AGN-241751 for the treatment of major depressive disorder
23 July 2018 - Phase 2 clinical study underway. ...
Posted by Michael Wonder on 23 Jul 2018
Precision medicine success hinges on diagnostics' clinical utility
23 July 2018 - The companion diagnostic plays a significant role in precision medicine. ...