FDA+ channel feed – Endpoints News

FDA+ channel feed

Amarin wins a blockbuster approval from the FDA. Now everyone can shift focus to the patent

6 years ago

FDA expert panel unanimously recommends approval for Horizon Therapeutics eye drug

6 years ago

What's next for Sarepta? A third DMD approval, analysts predict

6 years ago

Sarepta was stunned by the rejection of Vyondys 53. Now it's stunning everyone with a surprise accelerated approval

6 years ago

Stephen Hahn confirmed as new FDA chief

6 years ago

FDA slaps down Alkermes for misleading Vivitrol ads — don't forget vulnerability to opioid overdose

6 years ago

Foreign drug inspections decline as FDA hiring struggles continue

6 years ago

South Korea jails 3 Samsung execs for destroying evidence in BioLogics probe

6 years ago

FDA lifts hold on Abeona's butterfly disease therapy, paving way for pivotal study

6 years ago

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

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