Blog
RSS FeedPosted 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. ...
Posted by Michael Wonder on 04 Mar 2025
Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
3 March 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 02 Mar 2025
Teva and Medincell announce FDA acceptance of supplemental new drug application for Uzedy (risperidone) extended release injectable suspension as a treatment for patients with bipolar I disorder
25 February 2025 - Uzedy is currently approved in the US as a subcutaneous long-acting injectable for use every one or ...
Posted by Michael Wonder on 01 Mar 2025
Outlook Therapeutics resubmits biologics license application for ONS-5010 as a treatment for wet AMD to the US FDA
28 February 2025 - Outlook Therapeutics today announced it has re-submitted its biologics license application to the US FDA for ...
Posted by Michael Wonder on 28 Feb 2025
US FDA grants priority review to Sobi's supplemental biologics licence application for Gamifant (emapalumab-lzsg)
27 February 2025 - Sobi today announced that the US FDA has accepted the supplemental biologics license application for Gamifant (emapalumab-Izsg) ...