FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA offers first thoughts on neurodegenerative disease gene therapies

5 years ago

AstraZeneca's Farxiga gets rough FDA review date for groundbreaking move into chronic kidney disease

5 years ago

'N of 1' therapies addressed in draft FDA guidance

5 years ago

Roche gets a leg up in the anti-TIGIT race with first breakthrough designation for PhII winner tiragolumab

5 years ago

Recall report: Nostrum expands recall of diabetes drug metformin after carcinogen concerns

5 years ago

Bristol Myers Squibb walks on Opdivo's FDA nod for small-cell lung cancer after middling OS data couldn't back approval

5 years ago

AstraZeneca/Oxford score first vote of confidence as UK authorizes their Covid-19 vaccine

5 years ago

FDA lifts clinical hold on Audentes' gene therapy program after three patient deaths triggered alarms

5 years ago

With pipeline setbacks mounting, United snares priority voucher for inhaled formulation of PAH med Tyvaso

5 years ago

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

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