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FDA approves Covid-19 mAb for emergency use in immunocompromised

Drug Discovery World

It is approved in adults and adolescents (12 years of age and older weighing at least 40kg) who are moderate-to-severely immune compromised due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to Covid-19 vaccination.

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Cancer vaccine shows sustained improvement in survival rates

Drug Discovery World

Cancer vaccine mRNA-4157 (V940) in combination with Keytruda reduced the risk of recurrence or death by 49% in patients with resected high-risk melanoma, according to follow-up data presented at ASCO 2024. months after initial treatment. The follow-up of the Phase IIb study took place 34.9 It showed that the 2.5-year compared to 55.6%

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The regulatory round-up: Five important FDA approvals

Drug Discovery World

The US Food and Drug Administration (FDA) has granted marketing authorisations to several new therapeutics over the last month that will have a significant impact on areas of unmet need and the evolution of future treatments.

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FDA approves Gohibic for emergency use in Covid-19 patients

Drug Discovery World

Gohibic (vilobelimab) has been granted an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of Covid-19 in hospitalised adults. A total of 369 patients were randomly assigned to the vilobelimab treatment group (six 800mg infusions) or the placebo group.

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This week in drug discovery (12-16 June)  

Drug Discovery World

Regulatory approvals and industry guidelines are key to the continued development and discovery of drugs, which is a common theme throughout this week’s news highlights, including an FDA approval for Pfizer, a NICE recommendation for AstraZeneca UK, and an update to the HER2 Breast Cancer Testing Guidelines.

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U.S. FDA APPROVES TICOVAC™, PFIZER’S TICK-BORNE ENCEPHALITIS (TBE) VACCINE

The Pharma Data

Food and Drug Administration (FDA) has approved TICOVAC (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older. 1 TICOVAC is the only FDA-approved vaccine to help protect U.S. Following today’s FDA approval, the U.S. 45 years ago.

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Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

The Pharma Data

More recently, the FDA announced regulatory approval for the first treatment for Covid-19. Dive into this week’s update for more details on the actions taken by the FDA in the ongoing response to the Covid-19 pandemic. FDA approves first treatment for Covid-19.