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 submitted vorvida for approval by the FDA in March, before the pandemic gathered pace in the US, and had been hoping for a third-quarter approval before the new pathway came into effect.

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 ...

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 ...

"I just want to start and reinforce that FDA has not abandoned the menthol product standard," Brian King, director of the FDA's Center for Tobacco Products, told a House Energy and Commerce ...

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 ...

Syphilis cases have increased nearly 80% from 2018 to 2022, CDC data shows. The first at-home, over-the-counter antibody test for syphilis received marketing authorization from the U.S. Food and ...

1 strain. The move would be several weeks ahead of last year’s version of the vaccine, which got FDA signoff on September 11. “Now is the time to get a dose with this surge,” Dr. Michael ...

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 ...

Her expertise is in personal finance and investing, and real estate. The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public ...