Drug Approvals

An approved drug is a formulation that has been validated for a therapeutic use by a ruling regulatory authority. Here, we cover the latest in big drug approvals and explore how these new therapies could impact the industry. 


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FDA decisions to watch in 2023

The agency is facing a busy year, with potential novel drug approvals ranging from gene therapies to RSV jabs

10 tips for improved drug development

Comprehensive strategies to save time and reduce cost in end-to-end clinical development

Pulling antibiotics from the fire

Can policy reform save a market in peril?

HIV: An ending in the balance

Incorporating cures into pharma's HIV epidemic equation

FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals

10 major drugs falling off the patent cliff in 2021

At some point, the patent cliff claims the high-rolling life of market exclusivity for all drugs — and 2021 is, of course, no exception.Although the industry has been flushed ...

The bullish half

The industry is split on whether or not the newest Alzheimer’s drug will survive

Improving the risk-reward calculus for clinical trials

How natural language processing and machine learning can boost success in drug development

BARDA wants you

After a year of historic deals, BARDA looks to recruit more partners in pharma

Making hydroxychloroquine great again

How a 65-year old drug became the center of partisan divide

Fighting COVID-19 with AI

Pharma companies are using technology to reinvent the drug discovery process

Fish oil salesmen

Pharma explores the promise and realities of prescription omega-3s

Pharma's next strange trip: The industry alters its state of mind on psychedelics

Will the hype around psychedelics turn into a bad trip for pharma? Or, as some have suggested, will they provide a future for mental health drug development that's bigger than...

Will pharma’s record-breaking race for a coronavirus vax pay off?

If a pharma company succeeded in developing a vaccine for the coronavirus in the timeframe many have promised, it would be a historic milestone for the industry.

The surge in cancer drug approvals — By the numbers

A new report shows that the number of FDA approvals for cancer drugs has shot up in the last few decades. What’s behind the rise?