FDA increases risk level of granola bar recall due to ‘adverse health’ effects
The U.S. Food and Drug Administration ( FDA) has elevated the risk of a recall of various granola bars.
FDA approves first rapid-acting insulin
According to the FDA, the medication quickly helps to lower mealtime blood sugar spikes to improve control of blood sugar in ...
Healio18h
FDA approves subcutaneous Merilog for glycemic control in diabetes
The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog ...
Agios Pharmaceuticals: Liver Toxicity Issues May Threaten Thalassemia Approval (Rating Downgrade)
Despite promising Phase 3 results, safety concerns, namely liver injury, have impacted Agios stock and could affect Pyrukund's approval and market adoption. Read the full report here.
Managed Healthcare Executive20h
FDA Approves Gomekli, First and Only NF1-PN Treatment for Both Children and Adults
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult ...
Healio23h
FDA approves Evrysdi tablets for spinal muscular atrophy
The FDA has approved Evrysdi in tablet form for patients with spinal muscular atrophy aged 2 years and older who weigh more ...
OS Therapies gears up for FDA meeting on cancer drug
NEW YORK - OS Therapies, Inc. (NYSE-A: OSTX), a small-cap biotech firm with a market capitalization of $42 million focusing on cancer treatment solutions, has announced the completion of its Phase 2b ...
Moderna Reports Fourth Quarter and Fiscal Year 2024 Financial Results and Provides Business Updates
Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizing ...
thehealthy1d
RFK Jr.’s New Role Will Likely Change 6 Longstanding FDA Practices, Says National Expert
A seasoned FDA compliance and regulations expert says you can watch for these major ways health intelligence may change for the public.
Managed Healthcare Executive1d
FDA Approves Expanded Label for Izervay, No Dosing Duration Limit
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
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 ...