FDA Grants Fast-Track Designation To Cannabis Withdrawal Syndrome Drug
U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...
Evolus Gets FDA Approval for Two Injectable Hyaluronic Acid Gels
Evolus said the Food and Drug Administration approved its injectable hyaluronic acid gels, known as Evolysse Form and Evolysse Smooth, in line with management expectations.
US FDA approves Evolus' 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.
Minnesota-invented patch for premature ejaculation gains FDA clearance
Maple Grove-based Morari Medical’s device “MOR” is a drug- and chemical-free approach for the common men’s sexual health ...
FiercePharma21h
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 ...
Neurology Advisor23h
FDA Approves Wearable Infusion Device for Advanced Parkinson Disease
The US Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only subcutaneous apomorphine infusion device for the treatment of motor fluctuations in ...
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 ...
Contract Pharma23h
FDA Greenlights Roche’s Evrysdi Tablet
New 5mg tablet offers the same established efficacy and safety as the Evrysdi oral solution for individuals living with spinal muscular atrophy.