FDA+ channel feed – Endpoints News

FDA+ channel feed

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

Sarepta CEO Doug Ingram pins gene therapy delay on Covid-burdened FDA, can't offer timeline for fix

5 years ago

A 'breakthrough' PD-1? From China? FDA says why not for rare cancer

5 years ago

Trelegy gets FDA thumbs-up for asthma, becoming first triple-combo therapy in the US

5 years ago

FDA knocks back Sarepta in Duchenne gene therapy race with Pfizer, but analysts urge caution

5 years ago

Roche nabs an FDA OK for Gavreto, triggering a heavyweight bout with rivals at Eli Lilly

5 years ago

BIO and a string of CEOs issue a call for FDA independence and against science-by-press-release

5 years ago

FDA sends warning letter to Mylan over 'inadequate' manufacturing processes at India plant

5 years ago

Bristol Myers snares another approval from the old Celgene pipeline, nabbing an overlooked OK

5 years ago

FDA releases PDUFA VI program report on combination products

5 years ago

New analysis shows inclisiran consistency in LDL-C reduction as Novartis readies for FDA decision

5 years ago

FDA drafts recommendations for studying cancer drugs in patients with CNS metastases

5 years ago

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