Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 20 Jul 2021
NeuroMetrix receives FDA breakthrough device designation for treatment of fibromyalgia with its wearable neurostimulation technology
20 July 2021 - NeuroMetrix today announced that its Quell device has received breakthrough designation from the U.S. FDA for treating ...
Posted by Michael Wonder on 20 Jul 2021
FDA approves Octapharma’s Octagam 10% for adult dermatomyositis
20 July 2021 - FDA approval based on positive results of international, multi-center ProDERM study. ...
Posted by Michael Wonder on 20 Jul 2021
EMA starts rolling review of COVID-19 vaccine Vidprevtyn
20 July 2021 - EMA’s CHMP has started a rolling review of Vidprevtyn, a COVID-19 vaccine developed by Sanofi Pasteur. ...
Posted by Michael Wonder on 20 Jul 2021
The Democratic majority depends on slashing drug prices
19 July 2021 - Last month, Republicans and Democrats in Congress came together to announce a historic bipartisan deal on ...
Posted by Michael Wonder on 20 Jul 2021
Kyowa Kirin announces EU approval for the self administration of Crysvita (burosumab) to treat X-linked hypophosphataemia
19 July 2021 - An additional option is now available to healthcare professionals to meet the needs of X-linked hypophosphataemia patients and ...
Posted by Michael Wonder on 20 Jul 2021
Japan becomes first country to approve Regeneron antibody cocktail (casirivimab and imdevimab) for the treatment of mild to moderate COVID-19
20 July 2021 - Regeneron Pharmaceuticals today announced that Japan's Ministry of Health, Labour and Welfare has approved Regeneron's casirivimab and ...
Posted by Michael Wonder on 20 Jul 2021
US FDA approves fexinidazole as the first all oral treatment for sleeping sickness
19 July 2021 - US FDA approves fexinidazole as the first all-oral treatment for sleeping sickness. ...
Posted by Michael Wonder on 20 Jul 2021
Albireo receives European marketing authorisation of Bylvay (odevixibat), the first drug treatment for progressive familial intrahepatic cholestasis
19 July 2021 - First approval in the world of Bylvay for the treatment of progressive familial intrahepatic cholestasis. ...
Posted by Michael Wonder on 20 Jul 2021
Streamlining proprietary ingredient categories
20 July 2021 - To help make the medicines application process more efficient, the TGA no longer allocates proprietary ingredient ...
Posted by Michael Wonder on 20 Jul 2021
Landmark PBS listing for Australians with bowel cancer
20 July 2021 - The Australian Government is providing access to a new treatment through the Pharmaceutical Benefits Scheme to support ...
Posted by Michael Wonder on 20 Jul 2021
Clinical trial national approach will benefit patients and our economy
20 July 2021 - Medicines Australia welcomes the clinical trial ‘one-stop-shop’ consultation, recently announced by the Australian Commission on Safety ...
Posted by Michael Wonder on 20 Jul 2021
Ardelyx provides regulatory update on new drug application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis
19 July 2021 - Ardelyx today announced that it received a letter from the U.S. FDA on 13 July 2021, ...
Posted by Michael Wonder on 20 Jul 2021
Almirall receives European Commission approval of Klisyri (tirbanibulin), an innovative topical treatment for actinic keratosis
19 July 2021 - Klisyri (tirbanibulin) is a topical first in class microtubule inhibitor indicated for the treatment of actinic keratosis ...
Posted by Michael Wonder on 19 Jul 2021
Foundation Medicine expands indication for FoundationOne Liquid CDx to be used as a companion diagnostic for Tabrecta (capmatinib)
15 July 2021 - Tabrecta is the first FDA approved MET inhibitor for patients with metastatic non-small cell lung cancer with ...
Posted by Michael Wonder on 19 Jul 2021
CMS proposes rule to increase price transparency, access to care, safety & health equity
19 July 2021 - The Centers for Medicare & Medicaid Services is proposing actions to address the health equity gap, ...