FDA Updates

Erdafitinib is first targeted therapy for FGFR3 or FGFR2 genetic alteration.

Safety alert issued requiring warning about concurrent alcohol use.

Evenity (romosozumab-aqqg) has been approved to treat postmenopausal women at high risk of bone fractures.

Women no longer require nine months of contraception post cessation of the drug.

First-ever dual-drug, single tablet for HIV offers lighter treatment regimen. 

Solriamfetol is approved for adult patients suffering from the effects of narcolepsy and OSA. 

The next-generation oral drug is the first to be approved specifically for secondary progressive multiple sclerosis in more than 15 years.

First drug approved for PPD use to remain under REMS program.

Indicated for breast cancer, and gastric or gastroesophageal junction adenocarcinoma. 

Eli Lilly creates generic Humalog priced 50% lower 

Restricted implants indicated for maintenance of opioid dependency. 

Sublingual form approved for short-term use.

The new device will increase real-time personalization and predictive diagnostics for patients.

Anthelmintic tablet for patients 6 years of age and older.

What you need to know about the von Willebrand factor (vWF)-directed antibody fragment.

What you need to know about the new botulinum toxin product.