FDA+ channel feed – Endpoints News

FDA+ channel feed

What controversy? Eli Lilly plots Alzheimer's BLA filing later this year as FDA taps more anti-amyloid drugs as breakthroughs

4 years ago

FDA slams Incyte's PD-1 over single-arm study, low response and trial deaths

4 years ago

Y-mAbs pushes back re-submission of its neuroblastoma BLA to end of 2021

4 years ago

New FDA documents show internal dissent on Aduhelm approval

4 years ago

Yescarta goes to China as Fosun Kite nabs historic first CAR-T OK

4 years ago

With FDA filing for key gene therapy pushed back 6 months, uniQure opens the pocketbook to refresh the pipeline

4 years ago

Woodcock defends Biogen's new Alzheimer's drug, says it has more supportive data than many past accelerated approvals

4 years ago

Consortium of 5 drug regulators plot path to increase harmonization through 2024

4 years ago

New DARPA-like NIH agency preps for reality as E&C unveils bipartisan Cures 2.0 draft bill

4 years ago

Biogen's new Alzheimer's drug serves as a rallying cry for drug pricing reforms

4 years ago

Spring regulatory agenda: What’s coming soon-ish from the FDA

4 years ago

After roller-coaster week, CRL forces a reckoning on Orphazyme investors — inflated shares plummet

4 years ago

Sen. Manchin to Biden: Don't nominate Woodcock for FDA commissioner

4 years ago

Novartis sets the tone for the radiopharma push with a prized acquisition winning breakthrough therapy designation

4 years ago

Medicaid commission to Congress: Increase rebates for accelerated approval drugs

4 years ago

Opinion: CMS needs to do FDA’s job and limit the use of Biogen’s pricey new Alzheimer’s drug

4 years ago

New Alzheimer's drug approval fallout: Public Citizen seeks removal of FDA's Woodcock, Cavazzoni and Dunn

4 years ago

FDA’s Cavazzoni calls for adcomms to ‘get back to the substance’

4 years ago

Recall report: Another drugmaker is pulling its version of metformin off shelves after a carcinogen scare

4 years ago

A snakebit biotech receives second CRL for reformulated pain med, potentially putting the kibosh on its chances

4 years ago

75M vaccine doses wasted: FDA spells out Emergent facility deficiencies at length in new memo

4 years ago

FDA authorizes about 10M J&J vaccine doses, trashes 60M more from troubled Emergent plant

4 years ago

An expensive watch, shell companies and fake invoices: How two Israeli traders tapped into a $100M global biotech insider trading ring

4 years ago

Harvard’s Aaron Kesselheim resigns from expert panel in wake of aducanumab OK, blasting FDA for ‘worst drug approval decision in recent U.S. history'

4 years ago

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