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FDA

Adam's Take

TherapeuticsMD path to drug approval still fuzzy, CytRx CEO on the hot seat

By Adam Feuerstein

Biotech

Novartis CAR-T cancer therapy wins expert support for FDA approval

By Adam Feuerstein and Damian Garde

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Biotech

FDA rejects Ocular Therapeutix eye drug, citing manufacturing issues

By Adam Feuerstein

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Biotech

Trump’s FDA may be lowering the standards for drug approvals. What’s the fallout?

By Adam Feuerstein

Pharmalot

FDA is reviewing generic applications faster, but what about those carryover fees?

By Ed Silverman

Pharmalot

Pharmalittle: Will index funds join the Mylan revolt? Sanofi plows big bucks into biologics

By Ed Silverman

Pharmalot

Trump plan to have industry pay for all product reviews will likely go nowhere

By Ed Silverman

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Pharmalot

Pharmalot, Pharmalittle: Pfizer gives a cancer drug away in the UK while waiting on coverage decision

By Ed Silverman

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Pharmalot

Pharmalot, Pharmalittle: Novartis is fined $49 million for paying bribes in South Korea

By Ed Silverman

Pharmalot

Lawmaker wants to make it easier for pharma to talk off-label drug use

By Ed Silverman

Pharmalot

How bad is the latest Lilly setback? Here’s what the wags are saying

By Ed Silverman

Pharmalot

Winners and losers: Who had a good week—and who didn’t

By Ed Silverman

Pharmalot

Pharmalot, Pharmalittle: Gottlieb deftly handles question at confirmation hearing

By Ed Silverman

Pharmalot

Cancer docs oppose ‘right to try’ laws over concerns about unintended harms

By Ed Silverman

Pharmalot

Pharmalot, Pharmalittle: Failure to renew user fees could mean 3,000 FDA layoffs

By Ed Silverman

Pharmalot

Say what? FDA warns a drug maker over a plant the UK regulator just blessed

By Ed Silverman

Pharmalot

Winners and losers: Who had a good week — and who didn’t

By Ed Silverman

Pharmalot

FDA warns Indian drug maker over serious quality control violations, again

By Ed Silverman

Pharmalot

FDA and European regulators reach a deal to honor each other’s plant inspections

By Ed Silverman

Pharmalot

Will an FDA rule for biosimilar names cost the health care system billions of dollars?

By Ed Silverman

Pharmalot

Pharmalot, Pharmalittle: Novartis may face penalties in Korea over bribes

By Ed Silverman

Pharmalot

Pharma urges FDA to delay rule on policing off-label marketing

By Ed Silverman

Pharmalot

The latest deal for a priority review voucher suggests prices are finally falling

By Ed Silverman

Pharmalot

Winners and losers: Who had a good week — and who didn’t

By Ed Silverman

Pharmalot

FDA pushes back against shortcuts in product testing

By Ed Silverman

Pharmalot

Forget about fake news, the FDA found fake quality control

By Ed Silverman

Pharmalot

FDA memo rebuffs many suggestions for expanding off-label marketing

By Ed Silverman

Pharmalot

FDA is making progress inspecting foreign drug plants, but could do better

By Ed Silverman

Politics

Were critical tweets the undoing of one Silicon Valley candidate to head FDA?

By Sheila Kaplan

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