FDA+ channel feed – Endpoints News

FDA+ channel feed

Federal judge rules against FDA in major stem cell oversight case

3 years ago

Once valued at more than $5B, Intarcia Therapeutics sees all of its execs depart and its final shot at FDA denied

3 years ago

Sanofi's Paul Hudson scores an FDA OK for a rare disease drug — after a lengthy R&D odyssey

3 years ago

After disappointing Wall Street last year, Denali touts new biomarker data hoping to forge clear path to FDA

3 years ago

Pharma-backed patient groups sue HHS over copay assistance programs

3 years ago

Florida sues FDA over dragging its feet on Canadian drug import program's approval

3 years ago

Corrected: FDA allows Curis to restart enrolling patients in leukemia trial as shares tumble 9%

3 years ago

Sanofi nabs priority review for hemophilia A program as pharma awaits FDA decision

3 years ago

Beam reveals what tripped up its base-edited, off-the-shelf CAR-T as it tries to clear FDA hold

3 years ago

Drug manufacturers must submit reports on quality problems to FDA. Almost half of sites still don't, new report finds

3 years ago

Incyte secures second FDA approval for bile duct cancer drug in mutated cancer type

3 years ago

Coin flip: Top analyst gives Amylyx ALS drug a 50% chance at approval as rare second adcomm approaches

3 years ago

French penny stock will no longer knock on FDA door for approval in a certain type of blood cancer

3 years ago

BioMarin nets conditional approval for valrox in Europe, marking the first hemophilia gene therapy

3 years ago

House investigates Trump’s ‘inappropriate’ pressure on FDA during the pandemic

3 years ago

Interchangeability without switching studies: FDA explains why a new Lucentis biosimilar may be a game-changer

3 years ago

Why does the FDA select certain drugs for adcomm meetings? Researchers want to know

3 years ago

So much to say, so little space. FDA-led studies assess risk information on social media

3 years ago

FDA commissioner spells out agency's top priorities, with a focus on dispelling misinformation

3 years ago

FDA converts Foghorn's partial hold on blood cancer study to a full pause

3 years ago

Charging for expanded access drugs: FDA to let companies recoup their costs over time

3 years ago

Pharvaris hits a snag with hereditary angioedema pill as FDA places hold on trials

3 years ago

Trick, or treat? FDA plans Halloween adcomm for Ipsen’s second chance at rare disease drug

3 years ago

Gilead secures first lenacapavir approval in Europe after lengthy manufacturing delays

3 years ago

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