FDA+ channel feed – Endpoints News

FDA+ channel feed

While Novartis combats generic onslaught in the courts, FDA approves first Gilenya copycats

6 years ago

The future of Ipsen’s new $1.3B drug is in doubt as safety fears force the FDA to slam the brakes on late-stage studies

6 years ago

Senate committee backs Stephen Hahn as the next FDA commissioner

6 years ago

FDA finalizes guidance on adaptive trial designs

6 years ago

FDA to Lexicon: Yeah, that's still gonna be a no from us

6 years ago

FDA approves 5 new costly drugs well ahead of PDUFA dates

6 years ago

Make that 2 new sickle cell disease blockbuster hopefuls OK’d by the FDA in just a few days

6 years ago

Roche, PTC will now get an FDA decision on their SMA drug in 6 months — facing off with Biogen, Novartis

6 years ago

Aquestive nabs FDA OK for oral film version of generic ALS drug

6 years ago

FDA releases 81 product-specific guidances

6 years ago

New epilepsy company on the block wins FDA approval for made-in-Korea drug to treat focal seizures

6 years ago

Five drugs, including two Novartis therapies, win EMA endorsement

6 years ago

EMA finalizes clinical development guideline for new gout treatments

6 years ago

In a first, FDA green-lights use of a Chinese built cancer therapy — and more are coming

6 years ago

Amarin emerges from an expert panel review with a clear endorsement for Vascepa and high odds of success when the FDA weighs in formally

6 years ago

Ahead of FDA decision on BTK drug, Amgen-partnered BeiGene is one step closer to China OK for PD-1

6 years ago

FDA to revoke orphan designation for opioid addiction drug Sublocade

6 years ago

Decrying 'arbitrary and capricious' action, RegenxBio sues FDA over clinical holds on gene therapy

6 years ago

HHS is taking Gilead to court, seeking damages for infringing government HIV patents

6 years ago

RegenxBio runs into partial hold for anti-VEGF gene therapy as FDA investigates delivery device

6 years ago

FDA renames and restructures oncology office

6 years ago

Is FDA doing enough to bring biosimilars to market? Experts discuss

6 years ago

Make room for poop transplants, even if a stool-based therapy is eventually approved — insist doctors and patients in FDA hearing

6 years ago

As resistance to standard antibiotics grows, RedHill's H. pylori regimen secures FDA approval

6 years ago

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