MedPage Today4h
FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes
The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and ...
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.
What’s the Difference Between the FDA and the USDA?
Explaining America’s weirdly complicated food inspection system, including who regulates poultry and eggs and how Robert F. Kennedy Jr. is involved ...
Healio9h
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 ...
SMA12h
FDA approves new tablet version of oral SMA treatment Evrysdi
The U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of Evrysdi (risdiplam), an approved oral ...
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 ...
US FDA approves Evolus' two new anti-wrinkle gels
Evolus said on Thursday the U.S. Food and Drug Administration has approved its two new anti-wrinkle injectable gels, expanding the company's product portfolio beyond its cosmetic injection Jeuveau.
FiercePharma1d
Astellas' eye med Izervay lands key FDA label update, amping up market battle with Apellis rival
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...
Monthly Prescribing Reference1d
Izervay Label Update Removes Limit on Treatment Duration for Geographic Atrophy
The Food and Drug Administration (FDA) has expanded the labeling for Izervay™ (avacincaptad pegol intravitreal solution) to include longer-term ...
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 ...
Ascendis Pharma A/S (NASDAQ:ASND) Q4 2024 Earnings Call Transcript
Q4 2024 Earnings Call Transcript February 12, 2025 Ascendis Pharma A/S beats earnings expectations. Reported EPS is $-0.68699 ...
Senators call on FDA to act against misleading weight-loss drug commercials
Commercials run by the telehealth company Hims & Hers have been placed under the microscope as lawmakers are calling out the advertisement of prescriptions for injectable weight-loss drugs without ...