The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...

The U.S. Food and Drug Administration has approved Onapgo (apomorphine hydrochloride) injection as the first and only ...

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

The U.S. Food and Drug Administration (FDA) approved Journavx (suzetrigine) oral tablets on Thursday as a first-in-class non-opioid analgesic to treat acute pain in adults. “Today’s approval ...

Acrivon Therapeutics, Inc. (ACRV) is up by 14 percent on Wednesday. The stock surged after the company announced that the U.S. Food ...

The ACR-368-tailored OncoSignature assay is being used to identify patients most likely to respond to the company's lead drug candidate ACR-368 in an ongoing, registrational-intent, phase IIb trial in ...

If you buy through a BGR link, we may earn an affiliate commission, helping support our expert product labs. For the first time in over two decades, the U.S. Food and Drug Administration (FDA) has ...

The Food and Drug Administration (FDA) has implemented new guidelines adjusting fees while extending the validity of the Certificate of Product Registration (CPR) for health products. Under ...

“The step-up approach is a reasonable way to approach this. It could play a role in reducing the overall exposure to opioids.” Whether doctors reach for the drug will most likely depend on its ...

Gameto, a $73 million-backed IVF startup founded by Under 30 lister Dina Radenkovic, announced this week that their product Fertilo has received Investigational New Drug clearance by the FDA.

Ozempic, the blockbuster GLP-1 drug that was originally approved to treat ... and no new safety risks were identified in this trial, he said. Sign up here to get The Results Are In with Dr ...