FDA clears Outset Medical of previous warning issues
Inc. (NASDAQ:OM), a medical technology company focused on innovating dialysis treatment, has resolved all concerns raised in a Warning Letter from the U.S. Food and Drug Administration (FDA) dating ...
Recursion: CDK7 Inhibitor Differentiation Is Initially Paying Off
Recursion is advancing REC-617, a promising reversible, non-covalent CDK7 inhibitor, showing potential in treating advanced ...
Alnylam: Waiting For Regulatory Updates In March
Alnylam awaits FDA decisions on Amvuttra & Fitusiran next month, poised to boost revenue, profitability, and share growth.
JD Supra8h
A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in ...
JD Supra8h
From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation
On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...
business11h
FDA leads seven African regulators to foster trust and accelerate access to medicines
The Ghana Food and Drugs Authority (FDA) has spearheaded a joint initiative with National Regulatory Authorities (NRAs) in seven African countries to foster trust, enhance regulatory reliance, and ...
Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
STAT16h
As officials prepare for WHO-led flu vaccine meeting, many wonder: Will the U.S. show?
Each year, flu experts from around the world gather to map out recommendations for next winter's flu vaccine. This year, it's ...
Racing Commission: 12 horses used illegal drug during All-American Futurity and undercards
All 12 Quarter Horses have been placed on the Steward's List meaning they cannot run in any licensed jurisdiction in North America until the adjudication process has been finalized. Both trainers were ...