Biotecnología

Biotecnología

AstraZeneca’s Ultomiris Approved by FDA for the Treatment of Adults with NMOSD
27/03/2024 - Long-acting C5 complement inhibitor offers patients with AQP4 Ab+ NMOSD the potential to live relapse-free.
FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects
27/03/2024 - FDA warns consumers not to use certain over-the-counter pain relief products containing lidocaine that are marketed for topical use in cosmetic procedures like microdermabrasion, laser hair removal,...
TKTX Company - 673879 - 03/25/2024
27/03/2024 - Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Dermal Source, Inc. - 663632 - 03/25/2024
27/03/2024 - Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Sky Bank Media, LLC dba Painless Tattoo Cream Co. - 666693 - 03/25/2024
27/03/2024 - Finished Pharmaceuticals/Unapproved New Drug/Misbranded
Pathogenesis and Diagnosis of Hepatitis A Virus and Other Biodefense Agents
27/03/2024 - A description of Gerardo Kaplan's research program and related publications.
Vascular-Based Biomarkers For Evaluation of Biological Product Safety and Efficacy
27/03/2024 - The main focus of this research program is to study the mechanisms by which biological products or pathogens alter the functioning or integrity of the vascular system in both vascular endothelial...
BioNTech Faces NIH Heat: Notice of Default Issued Over COVID-19 Vaccine Royalties
27/03/2024 - BioNTech intends to vigorously defend itself against all allegations of breach.
EPNextS Group and Frontage Labs Partner to Address ‘Drug Lag’ & ‘Drug Loss’ in Japan
27/03/2024 - Aim to combine their respective strengths to streamline the drug development process and bring novel treatments to market more efficiently.
FDA Roundup: March 26, 2024
27/03/2024 - The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
FDA Roundup: March 22, 2024
26/03/2024 - The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Italfarmaco S.p.A.’s Duvyzat Approved by FDA
26/03/2024 - Orally administered treatment for Duchenne muscular dystrophy approved in patients 6 years and older.
Johnson & Johnson’s Nipocalimab Earns Breakthrough Therapy Designation from FDA
26/03/2024 - Phase 3 clinical trial enrollment is underway.
AbbVie’s ELAHERE Granted Full Approval by FDA for Ovarian Cancer
26/03/2024 - Full approval was based on data from the confirmatory Phase 3 MIRASOL trial.
Altamira, Univercells Partner on Nanoparticle-Delivered mRNA Vaccines
26/03/2024 - Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform.
Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement - 03/05/2021
26/03/2024 - This is the CBER Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement.
AbbVie Agrees to Acquire Landos Biopharma
26/03/2024 - Aims to advance the clinical development of NX-13, a differentiated, first-in-class, oral asset.
A groundbreaking AI tool for liver disease diagnosis
26/03/2024 - In a significant advancement for the diagnosis of diffuse liver diseases, Quibim (Valencia, Spain), has unveiled its latest product, QP-Liver, a new AI-driven tool designed to...
Improving Medication Adherence and Patient Experience by Researching Patient Perceptions of Generic Drugs
24/03/2024 - OGD conducts and funds research to better understand how we can best educate patients and health care providers about generic drugs
Idorsia’s TRYVIO Approved by FDA for the Treatment of Hypertension
24/03/2024 - Idorsia plans to make TRYVIO available to the millions of patients in the US who are not controlled on other drugs in the second half of 2024.