Biotecnología
Biotecnología
C3TI Areas of Interest
27/05/2024 -
C3TI's areas of interest span drug development programs, therapeutic areas, and disciplines. Learn more.
Centogene and Evotec Discover New Potential Treatment for Gaucher Disease
16/05/2024 -
Companies amend existing drug discovery partnership for Evotec to lead continued development.
FDA Roundup: May 14, 2024
16/05/2024 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Central Admixture Pharmacy Services, Inc. - 674736 - 03/29/2024
16/05/2024 -
CGMP/Drug Products/Adulterated
Science & Research (Biologics)
16/05/2024 -
Listing of research programs conducted by CBER scientists and their published scientific articles classified according to the type of work being done: such as general biologics research, allergenics...
Vaccines Research
16/05/2024 -
List of Vaccines Research.
Types of FDA Inspections
16/05/2024 -
The FDA conducts several types of inspections to help provide access to needed medical products and to protect consumers and patients from unsafe products:
Teva Names New Executive Vice President of Teva Global Operations
16/05/2024 -
Matthew Shields joins Teva with over 25 years of experience in the global biopharmaceutical and animal health industries.
MAbxience Names New Chief Executive Officer
14/05/2024 -
Jurgen Van Broeck brings experience and a proven track record in the pharmaceutical and biosimilar industries.
WestGene’s mRNA Therapeutic Cancer Vaccine Approved by FDA
14/05/2024 -
Offers new hope to patients with advanced EB virus-related cancers.
5 Prime Sciences, Lilly Partner to Advance Cardio-Metabolic Disease Drug Development
14/05/2024 -
Integrates Lilly's cardio-metabolic disease expertise with 5 Prime Sciences' discovery and validation of drug targets.
FDA Roundup: May 10, 2024
14/05/2024 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or Repair
14/05/2024 -
FDA issued final guidance to provide clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The guidance seeks to ensure consistency while promoting...
EPA, FDA, and USDA Issue Joint Regulatory Plan for Biotechnology
14/05/2024 -
The U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the U.S. Department of Agriculture have developed a plan to update, streamline, and clarify their regulations and...
Drug Trials Snapshots: OGSIVEO
14/05/2024 -
Drug Trials Snapshots: OGSIVEO
Boehringer Ingelheim Inks Deal to Expand Patient Access to adalimumab-adbm Injection
14/05/2024 -
Will manufacture its Humira biosimilar for Quallent.
ARTBIO, Nucleus RadioPharma Enter Manufacturing & Supply Pact
08/05/2024 -
Nucleus to manufacture GMP-Grade therapeutic products containing Radioisotope Pb-212 to support clinical trials.
FDA Roundup: May 7, 2024
08/05/2024 -
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
bluebird bio Completes First Commercial Cell Collection for LYFGENIA
07/05/2024 -
One-time gene therapy for the treatment of sickle cell disease was approved by the FDA in December 2023.
July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
07/05/2024 -
July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
CDER Center for Clinical Trial Innovation (C3TI)
07/05/2024 -
Enable and amplify existing and future CDER clinical trial innovation through enhanced communication and collaboration
