Blog
RSS FeedPosted by Michael Wonder on 26 Jul 2019
Surrogate endpoints in randomised controlled trials: a reality check
27 July 2019 - At the 24th Congress of the European Hematology Association in June, 2019, the results of the BELLINI ...
Posted by Michael Wonder on 26 Jul 2019
Breakthrough drugs raise worries over higher costs
25 July 2019 - Potential breakthroughs in medical treatment for serious diseases are turning what was once “the stuff of ...
Posted by Michael Wonder on 26 Jul 2019
Matinas BioPharma receives qualified infectious disease product and fast track designations from U.S. FDA for MAT2203 for the treatment of cryptococcal meningitis
25 July 2019 - Fourth QIDP and fast track designations granted by FDA for MAT2203. ...
Posted by Michael Wonder on 26 Jul 2019
FDA approves Feraccru with a broad label of treating iron deficiency in adults
26 July 2019 - Feraccru to be marketed as Accrufer in the USA. ...
Posted by Michael Wonder on 25 Jul 2019
Aptar’s nasal unidose device approved by US FDA for first needle-free rescue treatment for severe hypoglycaemia
25 July 2019 - AptarGroup today announced that its Unidose Powder System was recently approved by the U.S. FDA for an ...
Posted by Michael Wonder on 25 Jul 2019
Epizyme announces FDA filing acceptance of new drug application and priority review for tazemetostat for the treatment of epithelioid sarcoma
25 July 2019 - Company aligns with FDA on planned confirmatory study design for tazemetostat in epithelioid sarcoma. ...
Posted by Michael Wonder on 25 Jul 2019
U.S. FDA accepts Correvio's resubmitted new drug application for Brinavess (vernakalant)
25 July 2019 - NDA seeks pproval for Brinavess for the treatment of recent onset atrial fibrillation; PDUFA date set for ...
Posted by Michael Wonder on 24 Jul 2019
FDA approves Pfizer's biosimilar Ruxience (rituximab-pvvr), for certain cancers and auto-immune conditions
23 July 2019 - Pfizer today announced the United States FDA has approved Ruxience (rituximab-pvvr), a biosimilar to Rituxan (rituximab), ...
Posted by Michael Wonder on 24 Jul 2019
Aeglea BioTherapeutics receives FDA breakthrough therapy designation for pegzilarginase for treatment of arginase 1 deficiency
24 July 2019 - Designation follows recently reported ARG1-D Phase 1/2 data demonstrating clinical response in patients rreated with pegzilarginase. ...
Posted by Michael Wonder on 24 Jul 2019
FDA approves first treatment for severe hypoglycaemia that can be administered without an injection
24 July 2019 - The U.S. FDA today approved Baqsimi nasal powder, the first glucagon therapy approved for the emergency treatment ...
Posted by Michael Wonder on 24 Jul 2019
FDA seeks input on biomarker, endpoint glossary
24 July 2019 - Two-and-a-half years after its release, the US FDA is asking for input from the public on ...
Posted by Michael Wonder on 24 Jul 2019
U.S. dependence on China for medicine is a major problem
21 July 2019 - As tensions with China have escalated over the past year, Washington, D.C., is finally waking up ...
Posted by Michael Wonder on 24 Jul 2019
Merck's biosimilar to AbbVie's Humira wins FDA approval
24 July 2019 - The U.S. FDA approved Merck & Co Inc’s biosimilar to AbbVie's blockbuster rheumatoid arthritis treatment Humira, ...
Posted by Michael Wonder on 23 Jul 2019
Merck and Eisai receive third breakthrough therapy designation from FDA for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination treatment
23 July 2019 - Designation granted for potential first-line treatment of patients with advanced unresectable hepatocellular carcinoma not amenable to loco-regional ...
Posted by Michael Wonder on 23 Jul 2019
U.S. District Court orders FDA to reconsider application for final approval of Brixadi (buprenorphine) extended release injection for the treatment of opioid use disorder
23 July 2019 - The U.S. District Court for the District of Columbia granted Braeburn’s motion for summary judgment, vacating ...