FDA+ channel feed – Endpoints News

FDA+ channel feed

Cures 2.0: Bipartisan House bill would allow RWE to satisfy confirmatory trial requirements for accelerated approvals

4 years ago

Cassava's problems just got much worse as SEC launches probe into data manipulation claims — report

4 years ago

European drug regulator votes down Biogen's controversial Alzheimer's drug

4 years ago

Covid-19 roundup: Pfizer licenses its pill to the Medicines Patent Pool; NYC joins states in authorizing boosters for all adults ahead of FDA

4 years ago

Just the idea of Aduhelm's long-term financial risks has CMS jacking up premiums, deductibles for 2022

4 years ago

It’s Califf: Biden picks the former FDA commish to head back to the helm

4 years ago

FDA+ roundup: More than 2 years after a CRL, Lexicon is still battling the decision; UK pharma industry weighs direction of MHRA

4 years ago

Amid an already slow rollout, Biogen's Aduhelm could soon face price competition — report

4 years ago

Opinion: The drug pricing deal isn't really a victory for Dems, or a loss for PhRMA. But it could be a harbinger of change

4 years ago

Accelerated approvals under fire again as pivotal trials typically take about as long as confirmatory trials, research shows

4 years ago

House Oversight Committee digs in on McKinsey's conflicting ties with FDA, opioids, and blocking Humira competitors

4 years ago

Dems' $100B deal reduced further: Medicare drug price negotiations pushed to 13 years for biologics

4 years ago

FDA adcomm votes 12-1 against Levo Therapeutics' nasal spray for a disorder that causes insatiable hunger

4 years ago

FDA+ roundup: FDA chief scientist departs to be deputy surgeon general; New transparency on oncology accelerated approvals

4 years ago

Dems forge limited agreement on Medicare drug price negotiations

4 years ago

FDA pushes back decision on J&J, Legend's BCMA CAR-T

4 years ago

HHS seeks to pull Trump-era 'ticking timebomb' rule that would've put 95% of FDA regulations on the chopping block

4 years ago

In key win, AbbVie lands FDA approval for Allergan's blurred-vision eye drop

4 years ago

FDA safety review to hold up Moderna’s Covid-19 vaccine for teens until 2022

4 years ago

FDA clears Pfizer's Covid-19 vaccine for children ages 5-11

4 years ago

An Allergan psychiatric drug failed late-stage depression studies — but AbbVie is going for approval anyway

4 years ago

Only a pawn in their game: Orphan drug tax credit on the chopping block again under Dem spending bill

4 years ago

Pfizer, Novartis, Janssen and other biotechs sign onto NIH/FDA program to develop new gene therapies for rare diseases

4 years ago

FDA+ roundup: CDER's breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing

4 years ago

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