FDA+ channel feed – Endpoints News

FDA+ channel feed

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

Covid-19 claims another PDUFA victim as GlaxoSmithKline pushes back planned PD-1 rollout

5 years ago

Merck makes good on big CV gamble with vericiguat nod — but competition will be fierce

5 years ago

HHS, FDA dispute spills out onto Twitter

5 years ago

AstraZeneca keeps the ball rolling on Daiichi-partnered Enhertu, picking up 2nd indication in gastric cancer

5 years ago

Poll: Should Joshua Sharfstein or Janet Woodcock lead the FDA from here?

5 years ago

Janet Woodcock is in the running for FDA commissioner — what does that mean for the agency's future?

5 years ago

Industry, FDA begin to hammer out PDUFA VII details

5 years ago

Novartis gets breakthrough designation for Xolair successor, setting up spotlight for PhIII readout later this year

5 years ago

Janet Woodcock to be acting FDA commissioner while Biden team finalizes nominee — reports

5 years ago

Bayer wins priority review for CKD program finerenone after PhIII data showed a delay in disease progression

5 years ago

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