10
Jul
2023
Tag: FDA
21
Feb
2023
Bionest
Alzheimer’s Disease Update Part 1: Lecanemab Provides New Support for the Amyloid Hypothesis
What will the recent accelerated approval of anti-amyloid lecanemab mean for Alzheimers patients, and will it overcome stringent CMS reimbursement policies?
7
Nov
2022
Bionest
Down to the Wire: The Race Between Amgen and Mirati for KRAS-Inhibitor Approvals
Who is ahead in the race for KRAS-inhibitor approval? We explore the latest drug development updates for sotorasib and adagrasib.
24
Oct
2022
Bionest
A New Advance in the Treatment of Major Depressive Disorder
Could the FDA approval of Auvelity usher in a new class of antidepressants? The new oral treatment for depression works with the glutamate receptor NMDA.
27
Dec
2021
Bionest
Addressing Gene Therapy Uncertainties
Are we close to more streamlined and standardized approaches to gene therapy testing and regulations?
27
Apr
2020
Bionest
Actions Around Drug Pricing Centering on Insulin
An increasing number of diabetes patients face affordability challenges for their insulin. How are pharma companies and the government responding?
13
Apr
2020
Bionest
FDA Finalizes Gene Therapy Guidelines and Adds New Draft Guidance on Orphan Drug Exclusivity
The field of gene and cell therapy is flourishing. How is the FDA responding?
17
Feb
2020
Bionest
New Treatments for Alzheimer’s Disease? Maybe.
No new treatments for Alzheimer’s disease have been approved since 2003. What's on the horizon?
16
Dec
2019
Bionest
New Risk-Based Oversight of Software as a Medical Device
A review of new FDA draft guidance documents that describe how the agency plans to regulate software designed to aid clinical decision making.
9
Dec
2019