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FDA approves first-in-class oral antibiotic

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved Blujepa ( gepotidacin ) antibiotic for uncomplicated urinary tract infections (uUTIs) in female adults and paediatric patients aged 12 years old and over. The post FDA approves first-in-class oral antibiotic appeared first on European Pharmaceutical Review.

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A perfect storm for biotech stocks

World of DTC Marketing

According to STAT News “after a double-digit decline in 2021, the sector has fallen another 20% in the new year, erasing billions in value and leading even the most seasoned investors to question whether biotech has further to fall. Meanwhile, the Food and Drug Administration has delayed several drug approvals, and Sen.

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A scientific approach to irrational consumer choices

World of DTC Marketing

GOOD MORNING: The FDA is taking a scientific approach to evaluating direct-to-consumer (DTC) drug advertising, focusing on measuring consumer perceptions of the information presented in ads. Presenting quantitative information increased participants’ gist and verbatim recall of drug efficacy. ” Uh…no.

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How did pharma develop a vaccine so quickly?

World of DTC Marketing

For the COVID-19 vaccine, the Food and Drug Administration (FDA) set up rigorous standards for vaccine developers to meet. Rather than have patients fill out the paperwork online and get a specific time for their shot, Florida uses the cattle car mentality, leading to people waiting overnight.

Pharma 307
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Disruption in healthcare is coming

World of DTC Marketing

A new feature—a sensor that monitors changes in the heart rate for irregularities that can lead to strokes and heart failure—has just been approved by America’s Food and Drug Administration (FDA). The FDA’s stamp of approval for the Fitbit sensor is a big deal.

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US FDA grants Orphan Drug status to Avacta’s drug for soft tissue sarcoma

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to Avacta Group’s lead pre|CISION drug candidate, AVA6000, to treat soft tissue sarcoma. This status offers the drug developer some incentives, such as market exclusivity for seven years on obtaining FDA approval.

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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

UK-based pharmaceutical giant GSK has announced that the US Food and Drug Administration (FDA) has extended the review period of its new drug application (NDA) for the rare bone cancer drug momelotinib by three months. The drug is not currently approved in any markets globally.