Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

Clinical and commercial quality controls are eased as the FDA looks to expedite therapy approvals in areas of unmet need.

The FDA orders the recall of a nasal spray in the US after finding live microbes; immunocompromised patients are at greatest ...

The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing ...

As part of the Hogan Lovells Horizons 2025 life sciences event series, our cross-practice team recently gathered in Boston to discuss shifting regulatory paradigms under the Trump administration's ...

Roughly half a year after introducing the new regulatory pathway, the FDA has greenlit the first drug under its ultra-speedy—and controversial—Commissioner's National Priority Voucher (CNPV) pilot ...

Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson’s fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this ...

FDA and EMA have issued 10 guiding principles for AI in drug development with the intended goal of ensuring safety and ...

A troubled Indiana contract manufacturing plant recently acquired by Novo Nordisk is considered to not be in compliance with the FDA standards, a serious designation that could further delay the ...

A few recent examples of the FDA’s approach to drugs show how bad the agency’s risk aversion has become. The FDA has ...

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

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