FDA+ channel feed – Endpoints News

FDA+ channel feed

Amicus shares slammed as lead PhIII drug fails a key head-to-head test for Pompe disease — but the CEO still projects an FDA OK and bright future

5 years ago

Regeneron antibody earns nod for rare cholesterol disorder — but it ain't cheap

5 years ago

Fresenius Kabi pays $50 million to settle criminal charges

5 years ago

AbbVie adds to the Botox war chest with a 12th FDA approval — but competition is fast approaching

5 years ago

Eli Lilly racks up EUA for antibody cocktail — but the bigger challenge is still ahead

5 years ago

With Libtayo's second approval, Regeneron digs deeper into PD-1 dermato-oncology niche

5 years ago

Freeline Therapeutics slams the brakes on gene therapy trial plans as FDA seeks more clarity on manufacturing

5 years ago

TG Therapeutics scores conditional FDA go-ahead for a drug it's pitching as a safer PI3K

5 years ago

Bristol Myers Squibb earns long-awaited FDA nod for liso-cel, joining short list of lymphoma CAR-T winners

5 years ago

FDA blasts Merck's bid for adjuvant Keytruda in TNBC before adcomm, calling late-stage data 'questionable'

5 years ago

FDA slaps clinical hold on antibiotics trial after deaths in monkey trial spurred concerns

5 years ago

PTC whiffs on another Duchenne study, plans to go to FDA again anyway

5 years ago

FDA cites litany of errors at Lonza Houston plant at the center of Bristol Myers CVR debacle

5 years ago

Merck KGaA goes toe to toe with Novartis as FDA green-lights MET inhibitor

5 years ago

Prothena revives its former lead drug, aiming for a smaller population with more severe cases

5 years ago

Recall report: Apotex recalls 2 batches of blood-thinner injection after syringe mislabeling snafu

5 years ago

Innovent and Lilly win second China OK for Tyvyt in frontline NSCLC, ramping up pressure on king Keytruda

5 years ago

Bristol Myers Squibb turns in priority review voucher for supplemental indication on an old Celgene drug

5 years ago

FDA lifts clinical hold on Mustang Bio's lentiviral gene therapy, paving the way for quick jump into pivotal trial

5 years ago

Durect's non-opioid painkiller brushes aside checkered past, gaining FDA approval in shoulder surgeries

5 years ago

Inspections: GAO calls on FDA to plan for backlog, review alternatives

5 years ago

After rancorous threats and a clinical hold, Applied Therapeutics is set to resume pediatric galactosemia study

5 years ago

Though still struggling, Bellicum can resume trial on CAR-T hopeful after FDA lifts clinical hold

5 years ago

The FDA delays its decision on Biogen's controversial pitch on its Alzheimer's drug — and the biotech's shares soar

5 years ago

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