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RSS FeedPosted by Michael Wonder on 01 May 2023
US FDA accepts for priority review supplemental biologics license application and EMA validates application for Reblozyl (luspatercept-aamt) as first-line treatment of anaemia in adults with lower-risk myelodysplastic syndromes
1 May 2023 - Applications based on results from Phase 3 COMMANDS study in which first-in-class Reblozyl demonstrated a highly statistically ...
Posted by Michael Wonder on 28 Apr 2023
Takeda announces FDA acceptance of BLA resubmission for investigational subcutaneous administration of Entyvio (vedolizumab) for maintenance therapy in moderately to severely active ulcerative colitis
27 April 2023 - Takeda today announced that the US FDA)has accepted for review its biologics license application resubmission for ...
Posted by Michael Wonder on 25 Apr 2023
bluebird bio submits biologics license application to FDA for lovotibeglogene autotemcel (lovo-cel) for patients with sickle cell disease 12 years and older with a history of vaso-occlusive events
24 April 2023 - BLA submission based on data from the largest and most mature clinical development program for any ...
Posted by Michael Wonder on 21 Apr 2023
Quizartinib NDA review for patients with newly diagnosed FLT3-ITD positive AML extended by FDA
20 April 2023 - Daiichi Sankyo today announced that the US FDA has extended the review period for the new ...
Posted by Michael Wonder on 20 Apr 2023
Ardelyx resubmits new drug application to US FDA for Xphozah (tenapanor)
18 April 2023 - Company expects to receive goal review date in mid May. ...
Posted by Michael Wonder on 19 Apr 2023
US FDA accepts for priority review Taiho Oncology's supplemental new drug application for the use of trifluridine/tipiracil (Lonsurf) in combination with bevacizumab for refractory metastatic colorectal cancer
18 April 2023 - The supplemental new drug application is supported by data from the Phase 3 SUNLIGHT clinical trial, the ...
Posted by Michael Wonder on 18 Apr 2023
Hugel hit with another complete response letter from the FDA
18 April 2023 - Hugel's much anticipated US launch of its botulinum toxin product, Letybo, has experienced yet another setback. ...
Posted by Michael Wonder on 17 Apr 2023
IntelGenx announces FDA approval of Rizafilm for the treatment of acute migraine
17 April 2023 - Partner Gensco Pharma preparing to commercially launch Rizafilm across the United States as soon as is practicable. ...
Posted by Michael Wonder on 17 Apr 2023
Regulatory applications accepted across three regions globally for Abecma for earlier use in adults with triple-class exposed relapsed and/or refractory multiple myeloma
17 April 2023 - US FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental biologics license application and has assigned a ...
Posted by Michael Wonder on 14 Apr 2023
Alvotech provides regulatory update on AVT02 biologics license application
13 April 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license ...
Posted by Michael Wonder on 13 Apr 2023
U.S. FDA issues complete response letter for mirikizumab
13 April 2023 - Eli Lilly announced the US FDA has issued a complete response letter for the mirikizumab biologic license ...
Posted by Michael Wonder on 13 Apr 2023
FDA accepts application for Merck’s Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic gastric or gastro-esophageal junction adenocarcinoma
13 April 2023 - Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit ...
Posted by Michael Wonder on 08 Apr 2023
Accord BioPharma announces US FDA acceptance of biologics license application for proposed biosimilar trastuzumab HLX02
5 April 2023 - The biosimilar for Herceptin seeks to treat several forms of HER2 cancer. ...
Posted by Michael Wonder on 04 Apr 2023
FDA accepts Pfizer’s supplemental new drug applications for Braftovi + Mektovi
4 April 2023 - Supplemental new drug applications are supported by results from the PHAROS trial, evaluating the combination in ...
Posted by Michael Wonder on 04 Apr 2023
HUTCHMED completes rolling submission of NDA to US FDA for fruquintinib for the treatment of refractory metastatic colorectal cancer
31 March 2023 - NDA supported by data from global Phase 3 FRESCO-2 study in the US, Europe, Japan and Australia ...