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 04 Apr 2022
FDA approves Nobelpharma's Hyftor (sirolimus 0.2% topical gel)
4 April 2022 - Hyftor is the first topical treatment approved by the FDA for facial angiofibroma in individuals with tuberous ...
Posted by Michael Wonder on 04 Apr 2022
Alnylam announces three month extension of review period for new drug application for vutrisiran
4 April 2022 - New PDUFA goal date scheduled for 14 July 2022. ...
Posted by Michael Wonder on 04 Apr 2022
Acer Therapeutics’ Edsivo (celiprolol) granted FDA breakthrough therapy designation for vascular Ehlers-Danlos syndrome
4 April 2022 - Discussions on-going with FDA through special protocol assessment seeking agreement on planned pivotal Phase 3 DiSCOVER trial ...
Posted by Michael Wonder on 04 Apr 2022
Biocon Biologics’ partner receives positive EU CHMP opinion for biosimilar human insulin for IV infusion
1 April 2022 - Celerity Pharmaceuticals Uses Biocon Biologics’ Insulin Drug Substance to Develop the Product. ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...
Posted by Michael Wonder on 04 Apr 2022
FDA accepts Dupixent (dupilumab) for priority review in patients aged 12 years and older with eosinophilic oesophagitis
4 April 2022 - If approved, Dupixent would be the first medicine available in the U.S. indicated to treat eosinophilic esophagitis. ...
Posted by Michael Wonder on 04 Apr 2022
JW Therapeutics announces receipt of breakthrough therapy designation for Carteyva in mantle cell lymphoma in China
3 April 2022 - JW Therapeutics announced that the Center for Drug Evaluation of the National Medical Products Administration of China ...
Posted by Michael Wonder on 04 Apr 2022
Bluebird Bio has serious cash flow concerns; inability to strike reimbursement deals in Europe partly to blame
3 April 2022 - Bluebird bio is a highly innovative biotechnology company which develops gene therapies for several rare genetic ...
Posted by Michael Wonder on 04 Apr 2022
Here comes yet another new medicine for patients with MS
4 April 2022 - The TGA has approved Vumerity (diroximel fumarate). ...
Posted by Michael Wonder on 03 Apr 2022
House passes bill to limit cost of insulin to $35 a month
31 March 2022 - The bill stands to benefit millions of Americans with diabetes, but to become law, it will need ...
Posted by Michael Wonder on 03 Apr 2022
Cook Medical receives FDA breakthrough device designation for Zenith Thoraco+ endovascular system
31 March 2022 - Cook Medical’s Zenith Thoraco+ endovascular system (Thoraco+) has received breakthrough device Designation from the US FDA. ...
Posted by Michael Wonder on 02 Apr 2022
Novo Nordisk expands product offerings in Canada for the treatment of haemophilia A in both children and adults, with availability of Esperoct and Zonovate
1 April 2022 - Newly available treatments can help Canadians living with haemophilia A better manage their bleeding episodes ...
Posted by Michael Wonder on 02 Apr 2022
DT-216 granted FDA fast track designation for patients with Friedreich's ataxia
30 March 2022 - DT-216 is a novel GeneTAC gene targeted chimera small molecule designed to specifically target the GAA repeat ...
Posted by Michael Wonder on 02 Apr 2022
Califf admits controversy over FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
31 March 2022 - Robert Califf, the new head of the FDA, admitted Thursday that the agency’s controversial approval of ...
Posted by Michael Wonder on 02 Apr 2022
Y-mAbs announces submission of omburtamab biologics license application to FDA
1 April 2022 - Y-mAbs Therapeutics today announced that on 31 March 2022, the company completed the resubmission of its biologics ...