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. 

Articles

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Shutterstock 1818378929
Shutterstock 1818378929
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Shutterstock 1818378929

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
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PM2206-HERO-575x327-Development
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PM2206-HERO-575x327-Development

10 tips for improved drug development

Comprehensive strategies to save time and reduce cost in end-to-end clinical development
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Pulling antibiotics from the fire

Can policy reform save a market in peril?
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HIV: An ending in the balance

Incorporating cures into pharma's HIV epidemic equation
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2021-FDA-approvals
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2021-FDA-approvals

FDA year in review: 50 novel drug approvals and more

First-in-class and orphan drugs dominated the agency's 2021 approvals
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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 ...
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The bullish half

The industry is split on whether or not the newest Alzheimer’s drug will survive
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PM2012-HERO-880x500-Development
PM2012-HERO-880x500-Development
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PM2012-HERO-880x500-Development

Improving the risk-reward calculus for clinical trials

How natural language processing and machine learning can boost success in drug development
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PM2012-HERO-880x500-CoverStory
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PM2012-HERO-880x500-CoverStory

BARDA wants you

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

Making hydroxychloroquine great again

How a 65-year old drug became the center of partisan divide
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Fighting COVID-19 with AI

Pharma companies are using technology to reinvent the drug discovery process
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Fish oil salesmen

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