Project Vitality: Pfizer Pursues Vaccine R&D Expansion
Pfizer is planning a $470-million expansion of its Vaccine Research and Development facilities in Pearl River, NY.
Source: genengnews.com
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FDA Approves First Orally Administered Fecal Microbiota Product for the Prevention of Recurrence of Clostridioides difficile Infection
/PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Vowst, the first fecal microbiota product that is taken orally. Vowst is approved for the...
United States Carly Kempler Peter Marks Drug Administration Vowst To Seres Therapeutics Inc Biologics Evaluation
Source: prnewswire.com
Ascentage Pharma Passes GMP Compliance Audit by EU QP with Zero Deficiency, in an Achievement Signaling Global Recognition of the Company's Quality Management System
/PRNewswire/ -- Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB),...
Hong Kong Western Australia Prnewswire Ascentage Pharma Ascentage Pharma Dajun Yang Ascentage Pharma Global Manufacturing Center
Source: prnewswire.com
Biogen : Strong progress toward three potential launches in 2023; Company reports first quarter 2023 results and reaffirms full year 2023 guidance - Form 8-K
Strong progress toward three potential launches in 2023; Company reports first quarter 2023 results and reaffirms full year 2023 guidance First... | April 25, 2023
Chuck Triano Christophera Viehbacher Adam Keeney Jack Cox Samsung Bioepis Us Veteran Health Administration
Source: marketscreener.com
Biogen : Reports First Quarter 2023 Results
Press Release Cambridge, Mass. - Apr. 25, 2023 Strong progress toward three potential launches in 2023; Company... | April 25, 2023
Source: marketscreener.com
Bluebird bio Submits Biologics License Application (BLA) to FDA for lovotibeglogene autotemcel (lovo-cel) for Patients with Sickle Cell Disease (SCD) 12 years and Older with a History of Vaso-Occlusive Events
BLA submission based on data from the largest and most mature clinical development program for any gene therapy in sickle cell disease ... | June 18, 2023
Source: marketscreener.com
Ironwood to Present New Data at Digestive Disease Week® 2023 Demonstrating Potential of Linaclotide for Functional Constipation in Children and Adolescents Ages 6-17 Years-Old
– Pivotal Phase III data will be spotlighted via an oral presentation – – Additional efficacy and safety data will be featured across four posters – ... | June 18, 2023
Source: marketscreener.com
Bluebird Bio Submits Sickle Cell Gene Therapy Drug To FDA For Approval
Bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration...
Andrew Obenshain Exchange Commission Drug Administration Biologics License Application Priority Review Private Securities Litigation Reform Act
Source: pharmaceuticalonline.com
BLA Submitted for Lovo-cel, a One-Time Gene Therapy for Sickle Cell Disease
The BLA for lovotibeglogene autotemcel (lovo-cel), an investigational gene therapy for sickle cell disease, has been submitted to the Food and Drug Administration.
Drug Administration Biologics License Application Priority Review Orphan Drug Fast Track Regenerative Medicine Advanced Therapy
Source: empr.com
Daiichi Sankyo : Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA(219.5KB
Press Release Quizartinib NDA Review for Patients with Newly Diagnosed FLT3- ITD Positive AML Extended by FDA Tokyo and Basking Ridge, NJ - ... | April 20, 2023
United States Mark Rutstein Koji Ogiwara Daiichi Sankyo Jennifer Brennan Innovative Global Healthcare Company
Source: marketscreener.com