Ameluz® and RhodoLED® New Drug Application (NDA) and Investigational New Drug Application (IND) have successfully been transferred to Biofrontera Inc.

CUTERA, INC., a leading provider in aesthetic, dermatological solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted expanded indications for its truFlex muscle ...

Novo Nordisk said on Thursday it filed a marketing application to the U.S. Food and Drug Administration for CagriSema, its once-weekly next-generation weight-loss drug.

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Travoprost Ophthalmic Solution ...

Alphamab Oncology (stock code: 9966.HK) announced that the Investigational New Drug (IND) application for JSKN027, an ...

The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with ...

Drug cartels are producing a cheaper form of a lethal drug and DEA officials here in the metro say the stuff has made its way ...

The firm expects to begin the Phase I trial in HER2-positive breast and gastric cancers in the first half of 2026.

Aldeyra submitted the single successful trial to the FDA over the summer and the agency accepted the resubmitted NDA for ...

The US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat ...