Drugmaker Innoviva Specialty Therapeutics announced today that the US Food and Drug Administration (FDA) has accepted its new ...

The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee ...

Argenica Therapeutics Ltd ( ($AU:AGN) ) has shared an announcement. Argenica Therapeutics has encountered a clinical hold from the US FDA on its ...

AXS-14 (esreboxetine) is a highly selective and potent norepinephrine reuptake inhibitor for the management of fibromyalgia ...

Eton Pharmaceuticals’ new drug application (NDA) for Khindivi, an oral solution of hydrocortisone, has received US Food and ...

ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE: PFE), for vepdegestrant for the treatment ...

Abbisko Therapeutics Co., Ltd. (02256.HK) today announced that the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for pimicotinib, a highly selective ...

In JAMA, the FDA's Makary and Prasad said they will focus on modernizing review processes and lowering drug costs but don't outright mention precision medicine.

Kura Oncology won FDA priority review for its drug the day before announcing new data at ASCO 2025 showing remission in about ...

XP 8121 is a combination drug meant to better control hypothyroidism, in part by moving its common therapy, levothyroxine, ...

Novo Nordisk NOVO.B2.86%increase; green up pointing triangle said the Food and Drug Administration accepted its submission of a new drug application for a Wegovy pill to treat obesity amid a tense ...

SHELTON, CT / ACCESS Newswire / June 4, 2025 / NanoViricides, Inc., a publicly traded company (NYSE Amer.:NNVC) (the “Company ...