regulatory

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David Hallal, Scholar Rock's chairman and chief executive

Manufacturing issues block FDA nod for Scholar Rock SMA drug

Unresolved issues at a manufacturing plant operated by Novo Nordisk have led to a complete response letter for Scholar Rock's SMA drug apitegromab.

Sales & Marketing

What can FDA really do about DTC pharma advertising?

What legal hurdles does the FDA face in changing the rules for broadcast advertising? And what should the industry be doing to prepare for changes?

News

Flood of warning letters follows DTC ad clampdown

The FDA has lost no time following through on its plan to tighten up DTC advertising of medicines, sending out dozens of untitled and warning letters.

News

FDA's Makary explains 'overdue' pharma ads crackdown

FDA Commissioner Marty Makary has called DTC ads for medicines a "public health crisis" as the industry prepares for a regulatory crackdown.

News

RFK Jr expands ACIP ahead of highly anticipated meeting

Five members have been added to a controversial CDC vaccines panel ahead of a meeting this week that could have an impact on US immunisation policy.

News

Intercept pulls Ocaliva off the market in the US

Alfasigma's $800m buyout of Intercept is starting to look like a poor bet as its only product, Ocaliva, is pulled from the market.

Manufacturing issues block FDA nod for Scholar Rock SMA drug

What can FDA really do about DTC pharma advertising?

Flood of warning letters follows DTC ad clampdown

FDA's Makary explains 'overdue' pharma ads crackdown

RFK Jr expands ACIP ahead of highly anticipated meeting

Intercept pulls Ocaliva off the market in the US

Lily gets FDA nod for SERD-CDK 4/6 combo in breast cancer

Discover a new era of healthcare panel engagement: Grounded ...

regulatory

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