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 ...

But armed with the FDA’s nod, it’s shooting for roughly $300,000 in revenue for 2024 and $3.5 million for 2025, she said. To prepare for those sales, OxiWear will need to ramp up manufacturing ...

1 lineage, and the FDA recommended manufacturers also target the JN.1 subvariant KP.2. Pfizer, Moderna and Novavax previously told federal regulators their vaccines would be available in August ...

The agency updates and modifies the alerts as needed. Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. Hickory Hollow Jerky, a Eufaula, AL, establishment ...

FIVE ON YOUR HEALTH TONIGHT VACCINE EXPERTS FOR THE FDA WILL MEET WEDNESDAY TO DISCUSS A NEW COVID 19 BOOSTER SHOT FOR THIS FALL. SO HERE TO ANSWER QUESTIONS IS DOCTOR SIMONE WILDES, AN INFECTIOUS ...

“We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” said FDA vaccine chief Dr ...

Democratic Reps. Ayanna Pressley of Massachusetts and Shontel Brown of Ohio pressed the FDA in a letter to finalize the proposed rule for banning certain salon-grade and at-home hair straighteners.

1 variant that began circulating widely in the U.S. last winter. The drugmakers started making the new doses in June after the FDA advised them to freshen the formulas to match the version of the ...

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