FDA+ channel feed – Endpoints News

FDA+ channel feed

Groups seek clarity on interchangeability in BsUFA III

5 years ago

Vivek Ramaswamy's 'vant' brainchildren keep bearing fruit with Urovant's FDA nod for incontinence med vibegron

5 years ago

Altimmune shares slide as the FDA flashes a red light for the IND work on their intranasal Covid-19 vaccine

5 years ago

FDA slaps a hold on Voyager's lead gene therapy over 'MRI abnormalities'

5 years ago

FDA greenlights second Ebola treatment in three months, handing new OK to Ridgeback's Ebanga

5 years ago

The FDA slaps a hold on uniQure's hemophilia B gene therapy as researchers explore a case of liver cancer in latest setback for a booming field

5 years ago

Best-selling Tagrisso further outpaces an upcoming J&J rival, winning approval in new NSCLC indication

5 years ago

It's a big day for Moderna — and the world — as the FDA stamps an EUA on their vaccine. And there are some important lessons to remember

5 years ago

FDA unexpectedly delays roxa decision, foiling FibroGen's February rollout plans

5 years ago

FDA stiff arms Novartis in a surprise setback for their PCSK9 drug inclisiran

5 years ago

In groundbreaking move, FDA approves Myovant's relugolix as the first once-a-day pill for advanced prostate cancer

5 years ago

GlaxoSmithKline's Benlysta earns first FDA approval for lupus nephritis as competitors wait in the wings

5 years ago

Amgen sends first KRAS drug to the FDA, approval could follow swiftly

5 years ago

MacroGenics scores first FDA approval with breast cancer med Margenza in third-line patients

5 years ago

Novartis sets eyes on newly-acquired Alexion with breakthrough tag for rare disease hopeful iptacopan

5 years ago

Novartis earns adcomm's vote of support in comeback FDA review for Entresto in sought-after heart failure patients

5 years ago

Gilead’s Dan O’Day pulls the plug on the lion’s share of their filgotinib collaboration as the FDA erects a high safety barrier. What went wrong?

5 years ago

FDA docs give Moderna green light, while spotlighting differences with Pfizer

5 years ago

FDA slaps a hold on a star Regeneron cancer drug, pausing trial enrollment as cytokine storms trigger new tox tempest

5 years ago

Despite flopping pivotal trial, Novartis' Entresto will face adcomm firing line for holy grail heart failure patients

5 years ago

An EUA is coming, FDA tells Pfizer

5 years ago

Novartis’ $9.7B PCSK9 drug nabs first OK — now comes the challenge of finding a market

5 years ago

Advisory committee votes 17-4 to recommend FDA authorize Pfizer-BioNTech vaccine, opening door to rapid EUA

5 years ago

Sanofi accepts a lengthy delay as its hemophilia drug fitusiran resumes a PhIII after safety fears forced a halt

5 years ago

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