Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a ...

Clene is planning to submit an application to the FDA in early 2026 requesting the accelerated approval of CNM-Au8 for ALS.

The latest update is out from Shanghai Junshi Biosciences Co., Ltd. Class H ( ($HK:1877) ). Shanghai Junshi Biosciences Co., Ltd. announced the ...

FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review.

The U.S. Food and Drug Administration approved an Investigational New Drug (IND) application using efficacy data solely from ...

SK Biopharmaceuticals Co., the biopharmaceutical unit of SK Group, said Tuesday it has received approval to market two of its ...

If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 ...

Praxis Precision Medicine said it had completed its pre-new drug application meeting with the Food and Drug Administration for its essential tremor treatment. The company said Thursday it expects to ...

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). Clinical studies have shown that centanafadine significantly reduces core symptoms of ADHD in ...

RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...

Relacorilant targets glucocorticoid receptor proteins, potentially redefining treatment for platinum-resistant ovarian cancer by inhibiting cancer cell proliferation. Clinical trials show relacorilant ...

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