In-Vitro Radiology Research 
pharmaphorum
OCTOBER 5, 2022
The US Government’s Biomedical Advanced Research and Development Authority (BARDA) has made an initial investment of approximately $55 million for rapid development of VIR-2482, the Vir Biotechnology’s investigational prophylactic monoclonal antibody (mAb) for seasonal and pandemic influenza viruses.
FDA Law Blog
AUGUST 18, 2024
By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. This amendment allowed sponsors with low or moderate risk devices to proactively employ the De Novo process.
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FDA Law Blog
DECEMBER 11, 2023
Mullen — With comments due on the proposed LDT rule last week, FDA wasted no time updating the Unified Agenda to indicate that a final rule may be published in April ( here ). We take this date with a grain of salt given the frequency with which these dates are missed and given the volume of comments filed. (It
The Pharma Data
MARCH 29, 2022
There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1,
The Pharma Data
NOVEMBER 18, 2021
New data from the AZD7442 COVID-19 PROVENT forestallment and Paraphernalia inpatient treatment Phase III trials both showed robust efficacity from a one- time intramuscular (IM) cure of the long- amusement antibody (LAAB) combination. In both PROVENT and Paraphernalia, AZD7442 was generally well permitted.
Cloudbyz
JULY 31, 2024
This revolution is enabling the growth of innovative biomarker-based precision medicine and cell and gene therapy, transforming both clinical research and post-market care. The landscape of modern medicine is rapidly evolving, driven by groundbreaking advancements in diagnostics.
The Pharma Data
MARCH 25, 2022
There is a growing body of evidence from multiple independent in vitro and in vivo (animal model) studies supporting the potential of Evusheld to protect against the BA.1, People not adequately protected by a COVID-19 vaccine may particularly benefit from pre-exposure prophylaxis with Evusheld.
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