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 ...

For example, unlike medicines digital therapeutics don’t yet have a specific identifier number that can be used in the reimbursement process, despite being FDA approved. Orexo is looking at ...

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 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 warned patients and prescribers about the risk of potential dental problems arising from the us ...

Lawmakers like Sen. Bernie Sanders say the FDA, the agency that regulates 80% of the country's food, hasn't done enough to protect consumers from poor health outcomes associated with these ...

The FDA said the vaccines will target the KP.2 strain, which is an offshoot of the omicron variant. The federal health agency said the decision applies to the vaccines manufactured by Pfizer ...

What is an FDA Calendar? Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment ...

and is a former advisory board member for Orexo AB; HJ has received speaker fees from AstraZeneca; JN is an employee of AstraZeneca. All authors were involved in data interpretation and manuscript ...

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