The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

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.

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for ...

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.

Pfizer’s Takeda-partnered blood cancer drug Adcetris (brentuximab vedotin) has been approved by the US Food and Drug ...

Evrysdi is a non-invasive, disease-modifying option that can be swallowed whole or dispersed in water for patients with ...

Marci English, head of biopharma and ophthalmology development at Astellas Pharma, said the FDA's change of heart will ...

A Minnesota company’s electrified men’s sexual health patch — once the victim of late night host Jimmy Kimmel’s jokes — is coming to consumers. Morari Medical, based in Maple Grove, raised millions of ...

The 5 mg risdiplam tablet provides the same efficacy and safety for spinal muscular atrophy as the currently available oral ...

Pfizer hopes a unique life-extension benefit for its Talzenna can serve to further expand the drug’s already ...

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 ...

The US Food and Drug Administration has approved Symbravo (meloxicam and rizatriptan) for the acute treatment of migraine with or without aura in adults.