regulatory

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'UK Only' red stamp on manufacturing facility

Deadline looms for post-Brexit label changes for UK meds

The MHRA has reminded pharma companies that from 1st January all medicines sold in the UK will have to comply with new labelling requirements.

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Applied Tx craters as FDA rejects lead product candidate

Applied Therapeutics plummets after the FDA turns down its marketing application for govorestat as a treatment for galactosaemia

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FDA probing cancer cases with Bluebird's CALD gene therapy

The FDA is scrutinising reports of haematological cancers in patients treated with bluebird bio's Skysona gene therapy for neurological disease CALD

Digital

Part 2 - Accelerating the Medical, Legal and regulatory (MLR...

Medical, legal, and regulatory review (MLR review) of promotional as well as non-promotional materials is one of the core responsibilities of medical and commercial teams within any life sc

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Court sides with EU on decision to revoke Ocaliva's license

Advanz Pharma's bid to keep its Ocaliva treatment for rare liver disease primary biliary cholangitis (PBC) on the EU market has ended in failure

News

Is Martin Makary Trump's pick for FDA Commissioner?

US President-elect Donald Trump is reported to be considering the nomination of Johns Hopkins surgeon and writer Martin Makary to lead the FDA

Deadline looms for post-Brexit label changes for UK meds

Applied Tx craters as FDA rejects lead product candidate

FDA probing cancer cases with Bluebird's CALD gene therapy

Part 2 - Accelerating the Medical, Legal and regulatory (MLR...

Court sides with EU on decision to revoke Ocaliva's license

Is Martin Makary Trump's pick for FDA Commissioner?

Ambrosia's sweet $100m round, and other biofinancings

Using AI-driven synthetic personas to take your insights fur...

regulatory

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