FDA+ channel feed – Endpoints News

FDA+ channel feed

HHS cracks down on AstraZeneca, Eli Lilly, Novartis, Novo Nordisk and Sanofi for limiting access to discounted drugs under the 340B program

5 years ago

House committee uncovers how Humira’s price spiked by 470% as AbbVie execs cashed bonuses tied to the hikes

5 years ago

FDA to CytoDyn: Those 2 Covid trials you keep touting both failed on all endpoints and your subgroup analysis doesn't help. Are we clear now?

5 years ago

SCOTUS declines to review Enbrel biosimilar case, teeing up 30+ years of exclusivity and $20B more for Amgen’s blockbuster

5 years ago

How to manufacture Covid-19 vaccines without the help of J&J, Pfizer or Moderna? Biolyse sees the difficulties up close

5 years ago

Apellis bags FDA nod for Soliris challenger with a different pathway to PNH — but can it slay the giant?

5 years ago

Internal Trump-era emails reveal a plethora of celebs, companies vying for FDA’s attention

5 years ago

Recall report: Novo Nordisk recalls samples of multiple insulin products after storage screw-up

5 years ago

Brazilian Covid variant in Illinois leads to a pause in shipments of Lilly’s mAb combo

5 years ago

Incyte’s PD-(L)1 inhibitor headed for an ODAC showdown next month

5 years ago

Third time’s the charm as Heron wins FDA nod for non-opioid anesthetic Zynrelef

5 years ago

FDA unveils six ICH guidelines ahead of meeting with Health Canada

5 years ago

Feds charge another CRO staffer with faking data in a GlaxoSmithKline pediatric asthma study

5 years ago

A closer look at the FDA’s more than 700 pandemic-related record requests to replace onsite inspections

5 years ago

Opinion: Adolescents can wait. The US needs to start donating Covid-19 vaccines to needy countries now.

5 years ago

RWE upstart maps a new global plan as investors pour in the latest mega-round

5 years ago

Biden administration signals that FDA may allow abortion pill access via mail even after the pandemic

5 years ago

EMA safety committee seeks more info on heart inflammation following Pfizer Covid-19 vaccine

5 years ago

Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug

5 years ago

Recall report: Acella pulls thyroid tablets after a raft of side effect reports; mislabeling causes Pfizer's Hospira to yank 2 lots of anesthetics

5 years ago

Biden administration backs a polarizing proposal to waive IP for all Covid-19 vaccines

5 years ago

FDA extends research agreement with MIT-licensed organ-on-chip systems

5 years ago

In quest to meet user fee goals, FDA’s performance continues downward trend

5 years ago

Opinion: Waiving Covid-19 vaccine IP could save lives, but where is the manufacturing capacity?

5 years ago

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