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 ...
US FDA approves GSK's combo meningococcal vaccine
The U.S. Food and Drug Administration approved British drugmaker GSK's combination vaccine to protect against meningococcal ...
Healio9h
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 Executive11h
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 ...
Healio15h
FDA approves two hyaluronic acid fillers for nasolabial folds
The FDA has approved Evolysse Form and Evolysse Smooth injectable hyaluronic acid gels, two dermal fillers from Evolus, the company announced in a press release.Both products are approved for use in ...
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 ...
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 ...
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 ...
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 ...