Por: RTTNews Health January 22, 2024
Autolus Therapeutics plc () said the FDA has accepted its Biologics License Application or BLA for obecabtagene autoleucel or obe-cel for patients with relapsed/refractory Adult B-Cell Acute Lymphoblastic Leukemia. The FDA has set a target action date of November 16, 2024. The company noted that the FDA is not currently planning to hold an advisory committee meeting to discuss the application. The BLA submission is based on data from the Phase 2... + full article
RTTNews USA Health November 27, 2023
Biopharmaceutical company Outlook Therapeutics, Inc. () announced Monday the receipt of the official minutes from the Type A meeting with the U.S. Food and Drug Administration (FDA) held in October 2023.The type A meeting was regarding the Complete Response Letter (CRL) dated... + más
Protalix Resubmits To FDA The BLA For Pegunigalsidase Alfa For Treatment Of Fabry Disease | RTTNews
Sarepta Therapeutics Updates Of BLA For Sarepta's Duchenne Muscular Dystrophy Drug Candidate | RTTNews
Abeona Therapeutics Inc. () announced the FDA has accepted and granted Priority Review for the Biologics License Application for pz-cel, the company's investigational autologous, COL7A1 gene-corrected epidermal sheets for the treatment of patients with recessive dystrophic... + más
Bluebird Bio Says FDA Accepts BLA For Lovotibeglogene Autotemcel For Priority Review | RTTNews
Somerville-based Bluebird Bio expects delay on FDA sickle cell drug application | The Boston Globe
CBS News USA Politics November 01, 2023
A panel of the Food and Drug Administration's outside advisers voiced few concerns Tuesday during a daylong wrestling with any potential risks posed by a new therapy that could cure sickle cell disease using a called .If approved by the FDA, the infusion called exa-cel,... + más
Study: Too few kids with sickle cell get stroke screen, care | Associated Press
FDA considers 1st CRISPR gene editing treatment that may cure sickle cell disease | ABC7
RTTNews USA Health June 21, 2023
bluebird bio, Inc. () announced Wednesday that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lovotibeglogene autotemcel (lovo-cel) for priority review. The agency has set a Prescription Drug User Fee Act (PDUFA) goal date of... + más
Bluebird Lake Placid Debuts In The Adirondacks | Forbes
Why Bluebird Backcountry Is The Most Unique Ski Resort In The U.S. | Forbes
The Boston Globe USA Business March 29, 2023
Bluebird Bio Inc. expects to fall short of its goal to seek regulatory approval for its sickle cell gene therapy by the end of March, the latest setback for the struggling biotechnology company.The company may be able to file the application in a few weeks, depending on when the... + más
Orlando Sentinel USA Sports March 25, 2023
Orangewood Christian 11, The Master’s Academy 1 Buzz: Austin Waring threw 5 innings of 1-run ball (0 earned runs) while allowing 4 hits and striking out 8 for Orangewood Christian. He lowered his season ERA to 0.78. Aiden McKee went 3-for-3 with a double, a walk, an RBI and a... + más
NFL Playoff Scenarios | ABC News
Le Krewe du Roi celebrates the state at 58th annual Mardi Gras Ball | The Advocate
The Hill USA Politics March 21, 2023
Reps. Gerald Connolly (D-Va.) and Don Bacon (R-Neb.), and Sens. Gary Peters (D-Mich.) and John Cornyn (R-Texas) top their respective lists of most effective lawmakers during the last Congress, according to from the nonpartisan Center for Effective Lawmaking (CEL). Connolly... + más
What we know about the new COVID-19 variant XBB | The Boston Globe
Meituan Beats, Week In Review | Forbes
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