Orexo has submitted its Vorvida digital therapy for the treatment of heavy drinking for approval by the FDA, setting up a possible launch in the second half of this year. The Swedish drugmaker ...

Now, the U.S. Food and Drug Administration (FDA) is working on a new study to get to the bottom of this issue and better understand how these metals are affecting women’s health. The decision ...

Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today announces that the company has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug ...

Women won’t see any changes to their routine mammograms. The new FDA rule will be seen in their results. In addition to finding out whether cancer was detected or not, women will also be able to ...

The Food and Drug Administration (FDA) has begun an expert, independent review of recent research on the health effects caused by heavy metals in tampons after lawmakers sounded the alarm on ...

The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Moderna and Pfizer for the 2024-2025 season. The updated mRNA vaccines, Comirnaty and Spikevax, were fully ...

Apple AirPods Pro 2 can soon be used as hearing aids, after they received Food and Drug Administration (FDA) clearance, in what experts call a game changer for the hearing aid market. The FDA on ...

The FDA's response to Ladapo in December rebutted each of his concerns, warning that vaccine "misinformation and disinformation" would result in fewer people getting vaccinated, which ...

The FDA granted emergency use authorization last week to an updated version of the Novavax shot, which includes a "monovalent (single) component" corresponding with the Omicron variant JN.1 strain of ...

ARS Pharmaceuticals' neffy, a needle-free nasal spray for allergies, receives FDA approval, driving stock price up 120%. Read ...

Orexo AB (publ), a specialty pharmaceutical company, develops and commercializes pharmaceuticals and digital therapies in the United States, European Union, and internationally. Its products ...

The FDA on Thursday said its marketing authorization of the product was its first ever for a over-the-counter hearing aid software device. Related Apple to release AirPods with built-in hearing ...