FDA+ channel feed – Endpoints News

FDA+ channel feed

Azar keen on nominating Brett Giroir, divisive assistant HHS secretary, to top job at FDA — report

6 years ago

Academics and researchers raise concerns with FDA’s plan for ‘integrated reviews’

6 years ago

FDA finalizes guidance on placebos and blinding for cancer trials

6 years ago

FDA fires off a warning on rare cases involving death, adverse liver events linked to misuse of 3 big hep C drugs

6 years ago

Bristol-Myers, AbbVie's multiple myeloma drug wins second EU nod as part of triple regimen

6 years ago

Decades in the making, Kyowa Hakko Kirin finally wins FDA approval for add-on Parkinson's therapy

6 years ago

FDA to roll out modernization plan in push for data interoperability

6 years ago

FDA asks why Novartis took two months to launch formal internal probe, after AveXis flagged data manipulation

6 years ago

Clearside Biomedical predicts its uveitis drug will be rejected, after FDA requests more data

6 years ago

Trump administration revives bid to get drug list prices on TV ads

6 years ago

Sir Andrew Dillon, NICE's first — and only — chief executive to step down next year

6 years ago

Finch grabs a $53M round designed to take their ‘breakthrough’ microbiome treatment through a potentially pivotal trial

6 years ago

SEC calls out little TherapeuticsMD for its insider contacts with analysts to boost share price, then halt rout

6 years ago

Webinar: Real World Endpoints — the brave new world coming in building franchise therapies

6 years ago

FDA decision on Vertex's CF triple will come just ahead of planned CEO shakeup

6 years ago

Payback? Analysts say Sarepta was blindsided by an FDA rejection driven by regulatory revenge

6 years ago

EMA and FDA historically agree on just about every new drug approval, but is that slowly changing?

6 years ago

Celgene and the scientist who championed fedratinib's rise from Sanofi's R&D graveyard win FDA OK

6 years ago

New research questions FDA’s reliance on and inability to enforce postmarketing requirements

6 years ago

One of the 'miracle cures' to hit the streets is really just industrial bleach — and it can kill you

6 years ago

FDA endorses new regimen for deadly drug-resistant tuberculosis rampant in developing world

6 years ago

The real-world evidence project at the FDA adds Syapse to its list of partners in a push past trial boundaries

6 years ago

As negotiations with England labor on, Scotland rejects routine use of Vertex's cystic fibrosis drugs

6 years ago

Questions pile up for Novartis as senators call on FDA to take action

6 years ago

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