Blog
RSS FeedPosted by Michael Wonder on 30 Jan 2025
Depemokimab applications accepted for review in China and Japan for asthma with type 2 inflammation and CRSwNP
28 January 2025 - Submissions based on data from positive SWIFT and ANCHOR trials. ...
Posted by Michael Wonder on 29 Jan 2025
Scholar Rock submits biologics license application to the US FDA for apitegromab as a treatment for patients with spinal muscular atrophy
29 January 2025 - Scholar Rock’s BLA submission is based on the Phase 3 SAPPHIRE trial that demonstrated a statistically significant ...
Posted by Michael Wonder on 29 Jan 2025
Alvotech and Teva announce filing acceptance of US biologics license applications for AVT05, a proposed biosimilar to Simponi and Simponi Aria (golimumab)
27 January 2025 - Alvotech and Teva Pharmaceuticals today announced that the US FDA has accepted for review biologics license applications ...
Posted by Michael Wonder on 29 Jan 2025
Depemokimab accepted for review by the EMA for use in asthma with type 2 inflammation and CRSwNP
28 January 2025 - If approved, depemokimab will be the first ultra long-acting biologic with 6 month dosing. ...
Posted by Michael Wonder on 28 Jan 2025
Saol Therapeutics announces FDA acceptance of new drug application for SL1009 for treatment of pyruvate dehydrogenase complex deficiency
28 January 2025 - Saol Therapeutics announced today that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 28 Jan 2025
Apellis receives approval of Syfovre (pegcetacoplan) in Australia for geographic atrophy
27 January 2025 - Apellis Pharmaceuticals announced today that the TGA has approved Syfovre (pegcetacoplan) for the every-other-month treatment of adult ...
Posted by Michael Wonder on 28 Jan 2025
GSK’s Shingrix new pre-filled syringe presentation accepted for review by EMA
27 January 2025 - If approved, the new presentation will offer a convenient administration option to healthcare professionals. ...
Posted by Michael Wonder on 28 Jan 2025
ImmunityBio announces EMA acceptance of marketing authorisation application for Anktiva for the treatment of patients with BCG unresponsive non-muscle invasive bladder cancer carcinoma in situ
27 January 2025 - Submission is based on the on-going QUILT 3.032 study in which 100 patients with Bacillus Calmette-Guérin (BCG)-unresponsive ...
Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain ...
Posted by Michael Wonder on 25 Jan 2025
X4 Pharmaceuticals announces EMA validation of marketing authorisation application for mavorixafor - licenced to Norgine for commercialisation in Europe
24 January 2025 - Following the licensing agreement with X4 Pharmaceuticals, Norgine is pleased to see the announcement from X4 ...
Posted by Michael Wonder on 23 Jan 2025
Stealth BioTherapeutics announces PDUFA action date extension for elamipretide to treat patients with Barth syndrome
23 January 2025 - New PDUFA action date of 29 April 2025, allows FDA additional time to complete review. ...
Posted by Michael Wonder on 23 Jan 2025
FDA and EMA accept applications for higher dose regimen of nusinersen in spinal muscular atrophy
23 January 2025 - Applications are based on data from the DEVOTE study, which demonstrate the potential for the investigational higher ...
Posted by Michael Wonder on 23 Jan 2025
Scilex announces that the US FDA has acknowledged the submission of our supplemental new drug application for Elyxyb in acute pain indication
22 January 2025 - Scilex today announced that the US FDA has acknowledged the submission of our supplemental new drug application ...
Posted by Michael Wonder on 22 Jan 2025
Replimune announces biologics license application acceptance and priority review for RP1 for the treatment of advanced melanoma
21 January 2025 - PDUFA action date of 22 July 2025, with priority review. ...
Posted by Michael Wonder on 18 Jan 2025
Arrowhead Pharmaceuticals announces acceptance of new drug application by US FDA of plozasiran for the treatment of familial chylomicronaemia syndrome
17 January 2025 - The new drug application is based on positive results from the Phase 3 PALISADE study. ...