U.S.-based PleoPharma announced yesterday that the FDA has granted it a fast-track designation for PP-01, a new ...

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.

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.

Maple Grove-based Morari Medical’s device “MOR” is a drug- and chemical-free approach for the common men’s sexual health ...

In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...

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 ...

Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...

New 5mg tablet offers the same established efficacy and safety as the Evrysdi oral solution for individuals living with spinal muscular atrophy.

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 ...

Amezalpat has been granted FDA fast track designation as treatment for patients with hepatocellular carcinoma.

Over the past nine years, patients with spinal muscular atrophy have seen the number of FDA-approved treatment options for ...

In the Phase 2 open-label Oral Anaphylm Symptom Intervention Study ("OASIS”) study, adults with Oral Allergy Syndrome (n=36) received Anaphylm under different conditions, including single and repeat ...