Blog
RSS FeedPosted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA ...
Posted by Michael Wonder on 10 Jun 2025
US FDA approves Merck’s Enflonsia (clesrovimab-cfor) for prevention of respiratory syncytial virus lower respiratory tract disease in infants born during or entering their first RSV season
9 June 2025 - Enflonsia is the first and only RSV preventive option administered to infants using the same dose ...
Posted by Michael Wonder on 09 Jun 2025
George Medicines announces FDA approval of Widaplik (telmisartan, amlodipine and indapamide), a new single pill combination treatment for hypertension in adults, including initial treatment
9 June 2025 - Commercialisation planning underway with US launch anticipated Q4, 2025. ...
Posted by Michael Wonder on 06 Jun 2025
Arvinas announces submission of new drug application to US FDA for vepdegestrant for patients with ESR1 mutated ER+/HER2- advanced or metastatic breast cancer
6 June 2025 - Arvinas today announced the submission of a new drug application to the US FDA with its partner ...
Posted by Michael Wonder on 05 Jun 2025
Linerixibat new drug application accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
2 June 2025 - GSK today announced the US FDA has accepted for review the new drug application for linerixibat, an ...
Posted by Michael Wonder on 04 Jun 2025
Chimeric Therapeutics CDH17 receives FDA fast track
4 June 2025 - Chimeric Therapeutics is pleased to announce that the US FDA has granted CHM CDH17 fast track ...
Posted by Michael Wonder on 04 Jun 2025
Cellectar granted US FDA breakthrough therapy designation for iopofosine I 131 in Waldenstrom macroglobulinemia
4 June 2025 - Designation supported by CLOVER WaM Phase 2 study data which reported an 83.6% overall response rate. ...
Posted by Michael Wonder on 03 Jun 2025
Pheast Therapeutics receives FDA fast track designation for PHST001 for the treatment of ovarian cancer
3 June 2025 - Pheast Therapeutics today announced that the US FDA has granted fast track designation to PHST001 for ...
Posted by Michael Wonder on 03 Jun 2025
FDA approves darolutamide for metastatic castration-sensitive prostate cancer
3 June 2025 - Today, the FDA approved darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC). ...
Posted by Michael Wonder on 02 Jun 2025
FDA accepts TransCon CNP NDA for priority review
2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application ...
Posted by Michael Wonder on 02 Jun 2025
Kura Oncology and Kyowa Kirin announce FDA acceptance and priority review of new drug application for ziftomenib in adults with relapsed or refractory NPM1 mutant AML
1 June 2025 - New drug application based on positive results from the Phase 2 KOMET-001 trial. ...
Posted by Michael Wonder on 29 May 2025
Zydus receives US FDA fast track designation for usnoflast, a novel oral NLRP3 inhibitor, for the treatment of amyotrophic lateral sclerosis
28 May 2025 - Usnoflast has previously also received orphan drug designation from the US FDA. ...
Posted by Michael Wonder on 29 May 2025
Patritumab deruxtecan biologics license application for patients with previously treated locally advanced or metastatic EGFR mutated non-small cell lung cancer voluntarily withdrawn
29 May 2025 - The biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's patritumab ...
Posted by Michael Wonder on 29 May 2025
Eton Pharmaceuticals announces US FDA approval for Khindivi (hydrocortisone) oral solution
28 May 2025 - Commercial launch expected the week of 2 June 2025. ...
Posted by Michael Wonder on 29 May 2025
Alcon announces FDA approval of Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease
28 May 2025 - Tryptyr is a first in class TRPM8 receptor agonist that rapidly stimulates natural tear production in patients ...