Biotecnología

Biotecnología

Telix Pharmaceuticals to Acquire IsoTherapeutics Group
28/02/2024 - Will further enhance Telix's in-house drug development capabilities.
Takeda Partners with Biological E. to Accelerate Access to Dengue Vaccine
28/02/2024 - Will enhance manufacturing capabilities to ensure a sustainable global supply of the vaccine.
FDA Roundup: February 27, 2024
28/02/2024 - The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Experic Announces New Facility in Dublin, Ireland
28/02/2024 - Will expand global clinical trial storage and logistics services to Europe.
LightEyez Limited - 665450 - 02/15/2024
28/02/2024 - CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug
2024 Meeting Materials, Vaccines and Related Biological Products Advisory Committee
28/02/2024 - This is the main page for the 2024 Meeting Materials, Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement - 05/16/2024
27/02/2024 - This is the main page for the Vaccines and Related Biological Products Advisory Committee (VRBPAC) May 16, 2024 Meeting announcement and meeting materials.
MAX Biopharma and Metaba Partner to Study Metabolomics
27/02/2024 - Will empower MAX BioPharma in its R&D efforts to develop novel drugs for some of the most debilitating and fatal diseases in humans.
Setting and Implementing Standards for Narrow Therapeutic Index Drugs
27/02/2024 - CDER's Narrow Therapeutic Index Drugs (NTI) working group works to resolve key NTI scientific and regulatory issues.
FDA Approves First Interchangeable High-Concentration, Citrate-Free Biosimilar to Humira
27/02/2024 - Teva is Alvotech’s strategic partner for the exclusive commercialization of SIMLANDI in the United States.
Bayer’s BAY 2927088 Granted FDA Breakthrough Therapy Designation for Lung Cancer
27/02/2024 - Early clinical evidence suggests that BAY 2927088 has the potential to benefit patients with NSCLC harboring a HER2 mutation.
FDA Science, Research, and Collaboration Advance Generic Medicines
26/02/2024 - In 2023, GDUFA-funded research helped expand our understanding of generic drug products, including complex products, and contributed to the development of advanced methods to characterize product...
FDA Approves AMTAGVI for Advanced Melanoma
26/02/2024 - WuXi Advanced Therapies receives approval for its Philadelphia site to begin the analytical testing and manufacture of AMTAGVI for Iovance.
Moderna 4Q Results
26/02/2024 - Drop in COVID-19 vaccine sales impacts results.
Biosimilars Guidances
26/02/2024 - This page lists Biosimilars Guidance documents.
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
26/02/2024 - Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek...
Hansa Biopharma Welcomes Evan Ballantyne as Chief Financial Officer
26/02/2024 - Ballantyne brings more than 30 years’ experience as a senior financial executive in both public and private life science companies.
QuVa Pharma, Inc. - 675685 - 01/26/2024
22/02/2024 - Compounding Pharmacy/Adulterated Drug Products
$31M Awarded: Ginkgo & SaponiQx to Develop Next-Gen Vaccine Adjuvants
22/02/2024 - Aim to use a combination of high-throughput empirical and AI/machine learning approaches to develop novel saponin-based adjuvants.
FDA Roundup: February 13, 2024
22/02/2024 - The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
INCOG BioPharma Boosts Filling Capacity with New OPTIMA Line
22/02/2024 - Will complement the company's existing multi-use filling line, bringing the company's total filling capacity to 140 million units per year.