FDA+ channel feed – Endpoints News

FDA+ channel feed

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

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

5 years ago

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

5 years ago

CDER lays out 2021 guidance agenda

5 years ago

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

5 years ago

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

5 years ago

Stakeholders weigh in on big data at EMA forum

5 years ago

Can struggling Iterum turn the corner to an antibiotic success story? They will know in six months

5 years ago

Albireo just advanced down to the 10-yard line at the FDA. And Ron Cooper’s team is getting prepped for the next big play

5 years ago

Biden institutes regulatory freeze on first day of presidency

5 years ago

Incyte's PD-1 priority review draws muted cheer — but analysts say it's all about getting a foot in the door

5 years ago

After stinging FDA setback, GlaxoSmithKline's ViiV finally notches US approval for long-acting HIV injection

5 years ago

Endpoints poll: Janet Woodcock takes the (interim) helm at the FDA. And a large majority of our readers want her to stay there

5 years ago

FDA guides on Covid-19 considerations in cell and gene therapy

5 years ago

Pieris finally vaults FDA hold on next-gen solid tumor hunter, clearing the path for mid-stage trial

5 years ago

FDA hits the brakes on Histogen's knee cartilage therapy, asking for more info on manufacturing process

5 years ago

Bristol Myers Squibb gets review date for Opdivo combo in gastric cancer, looking to overturn Keytruda's 3-year lead

5 years ago

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