FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA gives thumbs down for Mesoblast's aGVHD drug, saying one single-arm trial is not enough

5 years ago

Mesoblast asks for trading halt as PDUFA date slides by. What's up?

5 years ago

Solid gets another shot in DMD gene therapy race as FDA lifts hold. But is it too late to catch Pfizer, Sarepta?

5 years ago

Hahn insists FDA will stick to guidelines for Covid-19 vaccine decisions

5 years ago

District Court throws out Catalyst lawsuit alleging improper approval standards for rival LEMS drug

5 years ago

Eyeing their first approval, BridgeBio sends their first drug to the FDA and lands a speedy review

5 years ago

Slammed by FDA rejection, Aquestive vows to refile by end of year

5 years ago

One year after Fetroja approval, Shionogi expands label to include difficult-to-treat pneumonia

5 years ago

Covid-fattened shares crash as FDA puts a late-stage coronavirus vaccine trial on hold

5 years ago

FDA coffers are tapped for a down payment on a $300M Covid-19 PSA to ‘defeat despair’

5 years ago

Gilead wins a blockbuster consolation prize with EC, Japanese approvals for filgotinib — but that barely softens the blow of the FDA's CRL

5 years ago

FDA issues final rule allowing importation of drugs from Canada — but also keeps the power to revoke it

5 years ago

As FDA’s workload buckles under the strain, Trump again accuses the agency of a political hit job

5 years ago

Azar falls in line under Trump again. Experts say he's reinforcing a dark signal sent to the FDA

5 years ago

'Extremely political' — Trump neuters FDA's attempt to strengthen vaccine EUA

5 years ago

Updated: The micro-cap that tapped a mask-skeptic congressman for their Covid DSMB is applying for an EUA. Their evidence? 21 patients

5 years ago

Still held down by clinical hold, Novartis' Zolgensma falls further behind Biogen and Roche as FDA asks for a new pivotal study

5 years ago

Under fire, FDA to issue stricter guidance for Covid-19 vaccine EUA this week — report

5 years ago

Nearly two years after their narrow PhIII failure, Orphazyme gets speedy look at the FDA

5 years ago

NIH ‘very concerned’ about serious side effect in AstraZeneca's PhIII Covid-19 trial

5 years ago

Crown jewel in big Gilead buyout lands breakthrough designation for MDS

5 years ago

Marinus execs herald the rebirth of the one-drug biotech as a positive PhIII readout arrives for a rare disease

5 years ago

FDA shoots down Mallinckrodt's redemption attempt, spurns rare kidney disease drug for a second time

5 years ago

ICER criticizes cost of 8 targeted immune modulators for UC, recommending some deep discounts

5 years ago

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