FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA+ roundup: Adcomm date set for Cytokinetics heart drug; New generic drug guidance to reduce facility delays

3 years ago

FDA rejects Eiger's emergency use request for repurposed Covid-19 treatment

3 years ago

User fees in action: FDA unveils new shortened supplement review, rare disease pilots

3 years ago

Big Pharma heavyweights seek tweaks to FDA's clinical outcome assessment guidance

3 years ago

Another warning letter for Lupin as FDA identifies deficiencies at India-based site

3 years ago

Mesoblast sends in improved potency assay, looking to resubmit to FDA on acute graft-versus-host disease drug

3 years ago

FDA greenlights Otsuka subsidiary's bile duct cancer drug

3 years ago

Updated: Alnylam reinforces APOLLO-B patisiran data before heading to the FDA

3 years ago

Advocates, experts cry foul over Amylyx's new ALS drug, citing issues with price, PhIII commitment

3 years ago

BioMarin returns to FDA with a new pitch for hemophilia gene therapy — and a promise to get to the bottom of durability

3 years ago

Updated: After long and winding road, FDA approves Amylyx's ALS drug in victory for patients and advocacy groups

3 years ago

CMS spent more than $18B in four years on accelerated approvals with incomplete confirmatory trials, inspector general finds

3 years ago

Sanofi, Regeneron’s Dupixent scores another indication with first-ever approval for nodular skin disorder

3 years ago

Senate passes bill to rework animal testing requirements for drug developers

3 years ago

Cell and gene therapies from academia: EMA to help 5 projects going after unmet clinical needs

3 years ago

What more can we learn from DTC advertising? FDA's OPDP proposes new research

3 years ago

Real-time reviews for cell and gene therapies? Pfizer to FDA: Yes, please

3 years ago

Former Novartis drug for ultra-rare disease gets speedy FDA review

3 years ago

FDA's OTAT morphs into the Office of Therapeutic Products as new funds await

3 years ago

Manufacturing sites in Germany and China hit with warning letters over QC and cleaning issues

3 years ago

Now playing catch-up to bluebird, Vertex and CRISPR send in their pitch for blood disorder cell therapy

3 years ago

FDA slaps a partial hold on Avidity's mAb-siRNA therapy, pausing enrollment in muscle weakness disease study

3 years ago

Completely clean FDA-industry user fee deal attached to a must-pass government spending bill

3 years ago

Three withdrawals in advanced ovarian cancer spell trouble for PARP class

3 years ago

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