Blog
RSS FeedPosted by Michael Wonder on 29 Jan 2020
Key principles for the use of electronic product information for EU medicines
29 January 2020 - EMA, the Heads of Medicines Agencies of EU Member States and the European Commission (EC) have ...
Posted by Michael Wonder on 29 Jan 2020
Lilly receives FDA priority review for the selpercatinib new drug application
29 January 2020 - Eli Lilly announced today that the U.S. FDA has granted priority review for the new drug application ...
Posted by Michael Wonder on 29 Jan 2020
The FDA wants to know how Instagram influencers sway patient views on medicines
28 January 2020 - In 2015, Kim Kardashian promoted a morning-sickness pill to her millions of followers on social media, ...
Posted by Michael Wonder on 29 Jan 2020
Teva announces FDA approval of Ajovy (fremanezumab-vfrm) injection auto-injector
28 January 2020 - Teva Pharmaceuticals USA today announced that the FDA has approved an auto-injector device for Ajovy (fremanezumab-vfrm) injection. ...
Posted by Michael Wonder on 29 Jan 2020
Health Canada approves new indication for Invokana (canagliflozin) to reduce the risks associated with diabetic kidney disease in patients with type 2 diabetes
28 January 2020 - INVOKANA® is the only diabetes treatment in Canada approved to treat this patient group ...
Posted by Michael Wonder on 28 Jan 2020
Alkermes announces U.S. FDA acceptance of ALKS 3831 new drug application for treatment of schizophrenia and bipolar I disorder
28 January 2020 - Alkermes today announced that the U.S. FDA has accepted for review the company's new drug application ...
Posted by Michael Wonder on 28 Jan 2020
FDA continues strong support of innovation in development of gene therapy products
28 January 2020 - This is a pivotal time in the field of gene therapy as the FDA continues its ...
Posted by Michael Wonder on 28 Jan 2020
FDA accepts for priority review Dupixent (dupilumab) for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
28 January 2020 - If approved, Dupixent would be the first biologic medicine available in the U.S. for these children. ...
Posted by Michael Wonder on 28 Jan 2020
Jubilant Radiopharma Receives Approval from Health Canada for Drax Exametazime
27 January 2020 - Jubilant Radiopharma announced today that the company received approval from Health Canada for Drax Exametazine (Kit ...
Posted by Michael Wonder on 28 Jan 2020
Liquidia submits new drug application for LIQ861 (treprostinil) inhalation powder to U.S. FDA for the treatment of pulmonary arterial hypertension
27 January 2020 - Liquidia Technologies today announced the submission of its New Drug Application (NDA) to the U.S. FDA ...
Posted by Michael Wonder on 28 Jan 2020
US FDA approves only triple-combination tablet with Jardiance for adults with type 2 diabetes
27 January 2020 - Trijardy XR (empagliflozin/linagliptin/metformin hydrochloride extended release tablets) is a once-daily therapy combining three well-established treatments in one ...
Posted by Michael Wonder on 28 Jan 2020
Health Canada approves new indication for Stelara (ustekinumab) for the treatment of adults with moderately to severely active ulcerative colitis
27 January 2020 - In the Phase 3 pivotal trial, nearly 44% of patients receiving Stelara subcutaneous injections every 8 ...
Posted by Michael Wonder on 28 Jan 2020
Genentech submits supplemental biologics license application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer
26 January 2020 - Application is being reviewed under FDA's Real-Time Oncology Review pilot program. ...
Posted by Michael Wonder on 28 Jan 2020
EMA celebrates 25 years advancing public and animal health
27 January 2020 - This week marks EMA’s 25th anniversary. ...
Posted by Michael Wonder on 27 Jan 2020
FDA approves Merck’s Dificid (fidaxomicin) to treat Clostridioides difficile in children aged six months and older
27 January 2020 - Merck today announced the U.S. FDA has approved a new drug application for Dificid (fidaxomicin) for oral ...