The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for SYD-101 (atropine sulfate) to slow the progression of ...

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...

With a U.S. green light for its encapsulated cell therapy technology in the bag, privately held biotech Neurotech ...

Fast track was first introduced by FDA to expedite development and review of drugs to treat serious conditions lacking any FDA-approved drug,” commented Gary S. Jacob, Ph.D., Chief Executive Officer ...

The FDA has issued a recall for a nasal wash product ... In December 2024, Alcon Laboratories issued a recall of eye drops after discovering a fungal contamination in one of its products.

Caplin Steriles, part of Caplin Point Laboratories, obtained final approval from the US Food and Drug Administration (US FDA) ...

Samospharma Limited has vehemently denied any association with Aveo Pharmaceutical Pvt. Ltd, and Westfin Pharmaceutical Pvt.

The FDA granted fast track designation ... MD, of North Bay Eye Associates, discusses the benefits of Simple Drops from ImprimisRx for glaucoma. Geographic atrophy lesion location may be a ...