FDA+ channel feed – Endpoints News

FDA+ channel feed

Alvotech fails pre-approval inspection for its proposed Humira interchangeable biosimilar

3 years ago

FDA again finds Amylyx's ALS data lacking ahead of unusual second adcomm, while stressing dire need for treatments

3 years ago

FDA expands approval for Vertex's CF drug Orkambi to infants under two years of age

3 years ago

Biosimilar giant Biocon gets hit with 483 for issues at sites in Malaysia and India

3 years ago

Two years after a refuse-to-file, Y-mAbs lands an FDA adcomm for its 2nd neuroblastoma treatment

3 years ago

Amneal asks FDA to approve another new formulation of Parkinson’s combo drug

3 years ago

Azurity Pharmaceuticals continues its win streak as it bags another approval from the FDA

3 years ago

Top Boehringer Ingelheim drug gets FDA approval in rare skin disease

3 years ago

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

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