FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA plans to only issue pediatric exclusivity for new studies — not just those required under PREA

3 years ago

Updated: In another blow for NASH, FDA adcomm opposes accelerated approval of Intercept drug

3 years ago

First-of-its-kind gene therapy approved for healing wounds in “butterfly children”

3 years ago

AbbVie, Genmab land FDA OK for CD3xCD20 bispecific, catching up with Roche

3 years ago

CBER chief Peter Marks to consider 'alternatives' to clinical holds as they 'put shudders down investors' spines'

3 years ago

Bausch + Lomb and Novaliq win approval for dry eye disease treatment

3 years ago

AbbVie nabs seventh FDA approval for Rinvoq, adds Crohn’s disease indication

3 years ago

CDER leaders ready to implement swifter accelerated approval withdrawal process

3 years ago

Intercept's NASH hopeful gets preliminary thumbs down in FDA briefing docs

3 years ago

Merck defends antibiotic's approval from 2019 as BMJ investigation points to 'decline' in FDA standards

3 years ago

Priority review for Takeda’s ultra-rare blood clot ERT; FDA to give another look at Ardelyx’s CKD drug

3 years ago

Ex-FDA neuro chief Billy Dunn is taking a spin through the revolving door with biopharma — and that's a problem

3 years ago

FDA approves Allergan's newest hyaluronic acid injectable — with a new delivery system

3 years ago

FDA signals support for Pfizer’s RSV shot in adcomm docs before crucial vote

3 years ago

$97M gene therapy consortium aims to give companies and rare disease families a ‘north star’

3 years ago

FDA issues CRL to small Dutch biotech's breast cancer ADC as OS figures fail to impress

3 years ago

FDA adcomm backs accelerated approval of Sarepta's Duchenne gene therapy in close vote

3 years ago

Astellas wins approval for menopause hot flash treatment Veozah

3 years ago

Lawmakers call on FDA to create more uniformity in rare disease drug reviews

3 years ago

FDA adcomm votes in favor of ARS Pharmaceuticals' EpiPen alternative

3 years ago

FDA signs off on Otsuka, Lundbeck's antipsychotic for Alzheimer's agitation

3 years ago

Senate committee advances bipartisan PBM, FDA reforms with eight related amendments

3 years ago

FDA rejects bladder cancer therapy developed by Patrick Soon-Shiong’s ImmunityBio

3 years ago

AI and machine learning: FDA spells out specifics from drug discovery to manufacturing

3 years ago

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