Bionic Pancreas, Vyjuvek, Epkinly, Miebo, Rinvoq, RSVpreF, BCI

New FDA Approvals

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Join medical writer Dr. Emma Hitt Nichols as she relays information about the latest new FDA approvals from last week to help you stay updated. For clinicians, medical writers, medical science liasons, pharma sales reps, and other healthcare industry executives.

The FDA has approved the iLet Bionic Pancreas, which combines the iLet ACE Pump, iLet Dosing Decision Software, and a compatible continuous glucose monitor, providing an automated insulin delivery system for people with type 1 diabetes.

VYJUVEK, the first topical gene therapy, has received FDA approval for the treatment of dystrophic epidermolysis bullosa (DEB), a rare skin disease. It uses a nonreplicating HSV-1 vector to deliver the COL7A1 gene and restore skin structure.

EPKINLY has been approved as the first bispecific T cell engager (BiTE) for relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

MIEBO™, an ophthalmic solution, has been approved for the treatment of dry eye disease. It targets tear evaporation and is the first prescription drop specifically approved for DED.

The B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test System has received FDA authorization to aid in the risk assessment of pregnant women with hypertensive disorders, including preeclampsia, a leading cause of maternal morbidity.

RINVOQ (upadacitinib) has been approved for adults with moderately to severely active Crohn’s disease, providing an oral treatment option for patients who have had an inadequate response to tumor necrosis factor blockers.

Pfizer's RSVpreF vaccine candidate for respiratory syncytial virus (RSV) has received support for its efficacy and safety from the FDA's advisory committee. If approved, it could prevent RSV-related lower respiratory tract disease in infants.

The Connexus Direct Data Interface, a brain implant designated as a breakthrough device by the FDA, has the potential to help severely paralyzed patients regain communication abilities by deciphering neural signals.

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