Blog
RSS FeedPosted by Michael Wonder on 26 Mar 2025
Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis
25 March 2025 - Tolebrutinib was granted breakthrough therapy designation by the FDA based on positive results from the HERCULES Phase ...
Posted by Michael Wonder on 25 Mar 2025
Sungen Biomedical's world first new drug SGC001 monoclonal antibody receives FDA fast track approval
24 March 2025 - On 17 March 2025, US time, the world's first acute myocardial infarction antibody drug, SGC001, developed by ...
Posted by Michael Wonder on 23 Mar 2025
FDA approves new prostate cancer imaging agent Gozellix
21 March 2025 - Telix Pharmaceuticals today announces that the US FDA has approved its new drug application for Gozellix ...
Posted by Michael Wonder on 20 Mar 2025
Travere Therapeutics submits sNDA to FDA for approval of Filspari (sparsentan) for the treatment of focal segmental glomerulosclerosis
17 March 2025 - sNDA submission based on results from Phase 3 DUPLEX and Phase 2 DUET studies of Filspari in focal ...
Posted by Michael Wonder on 20 Mar 2025
Alvotech and Dr. Reddy’s announce FDA acceptance of biologic license application for AVT03, a proposed biosimilar to Prolia and Xgeva
18 March 2025 - Dr. Reddy’s Laboratories and Alvotech today announced that the US FDA has accepted a 351(k) biologic license ...
Posted by Michael Wonder on 19 Mar 2025
Scienture announces the US FDA approval of its NDA for SCN-102 to be launched as Arbli (losartan potassium) 10 mg/mL oral suspension
18 March 2025 - Scienture is pleased to announce the US FDA has approved SCN-102 with the brand name Arbli (losartan ...
Posted by Michael Wonder on 19 Mar 2025
US FDA grants priority review for new indication of finerenone for patients with common form of heart failure
17 March 2025 - Regulatory submission is based on positive results from the Phase 3 FINEARTS-HF study, which is part of ...
Posted by Michael Wonder on 17 Mar 2025
ANI Pharmaceuticals announces FDA approval for expansion of Iluvien label
14 March 2025 - ANI plans to begin marketing Iluvien in the US under the combined label later this year. ...
Posted by Michael Wonder on 13 Mar 2025
Seikagaku announces receipt of a complete response letter concerning the biologics license application in the US for SI-6603 (condoliase)
12 March 2025 - Seikagaku announced today that it has received from the US FDA a complete response letter concerning ...
Posted by Michael Wonder on 12 Mar 2025
Sydnexis announces FDA acceptance of new drug application and PDUFA date for SYD-101 for the treatment of progression of paediatric myopia
11 March 2025 - Sydnexis today announced that the US FDA has accepted its new drug application for SYD-101 and ...
Posted by Michael Wonder on 05 Mar 2025
FDA accepts supplemental biologics license application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
5 March 2025 - The filing application is based on data from the Phase 3 REGENCY study, where Gazyva/Gazyvaro showed superiority ...
Posted by Michael Wonder on 05 Mar 2025
Tevimbra approved in US for first-line treatment of advanced oesophageal squamous cell carcinoma in combination with chemotherapy
4 March 2025 - New indication based on results from a global Phase 3 trial demonstrating significantly improved overall survival ...
Posted by Michael Wonder on 05 Mar 2025
Capricor Therapeutics announces FDA acceptance and priority review of its biologics license application for deramiocel to treat Duchenne muscular dystrophy
4 March 2025 - FDA assigns PDUFA target action date of 31 August 2025. ...
Posted by Michael Wonder on 04 Mar 2025
Amneal’s BLA submissions for two denosumab biosimilars accepted for review by US FDA
3 March 2025 - Denosumab biosimilar candidates reference Prolia and Xgeva. ...
Posted by Michael Wonder on 04 Mar 2025
FDA files Corcept’s new drug application for relacorilant as treatment for patients with hypercortisolism
3 March 2025 - FDA assigns a PDUFA target action date of 30 December 2025. ...