FDA+ channel feed – Endpoints News

FDA+ channel feed

J&J beats Tagrisso and Takeda to the punch in key NSCLC subset, picking up new FDA approval

4 years ago

Bristol Myers' Opdivo leads the pack with FDA approval for resected esophageal or GEJ cancer

4 years ago

Bluebird’s new gene therapy among three new EMA OKs ahead of FDA

4 years ago

Takeda tees up priority review for storied CMV drug from its $62B Shire buyout

4 years ago

Eli Lilly sues HHS to halt any 340B-related monetary penalties

4 years ago

FDA revises and expands draft guidance on adjusting for covariates in RCTs

4 years ago

FDA adcomm to review FibroGen’s chronic kidney disease drug in July

4 years ago

FDA+ roundup: Flurry of guidance documents, updated risk criteria for Covid-19 mAbs, personnel moves and more

4 years ago

Opinion: Congress needs to take a hard look at what went on at Trump's White House during the pandemic

4 years ago

CMC holdup delays Iovance filing again — to 2022 — as FDA seeks more assay data for TIL therapy

4 years ago

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

4 years ago

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

4 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?

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 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

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