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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

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

4 years ago

The diabetes 'cure' Vertex acquired in its 2019 Semma buyout? It's headed to the clinic

4 years ago

Advocacy groups don't want Janet Woodcock to head the FDA, blasting ‘regulatory failures’ in opioid crisis

4 years ago

CDER lays out 2021 guidance agenda

4 years ago

Recall report: Nostrum recalls another lot of metformin as carcinogen concerns continue

4 years ago

Novartis' Q4 earnings clouded by regulatory setbacks on inclisiran, Zolgensma

4 years ago

Stakeholders weigh in on big data at EMA forum

4 years ago

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