FDA+ channel feed – Endpoints News

FDA+ channel feed

Sun Pharma temporarily halts shipments from manufacturing plant after FDA letter

3 years ago

FDA approves Biogen’s ALS drug tofersen, paving new road for accelerated pathway in neuro diseases

3 years ago

FDA hands Arbutus clinical hold on IND for hepatitis PD-L1

3 years ago

On Vertex and CRISPR Therapeutics’ heels, bluebird submits sickle cell gene therapy to FDA

3 years ago

FDA puts second Foghorn study on partial hold after serious heart event

3 years ago

FDA lifts nearly two-year hold on MaaT Pharma's microbiome therapy, opens door to PhIII

3 years ago

FDA pushes back PDUFA date for Daiichi's AML drug quizartinib over REMS updates

3 years ago

Outgoing regulatory chief details hiring and retention challenges for FDA inspectors

3 years ago

FDA greenlights Roche's Polivy, expanding label into first-line DLBCL combo therapy

3 years ago

FDA's pain adcomm debates clinical trial designs for opioid post-marketing trials

3 years ago

Ireland added to EMA/FDA joint generic inspection initiative

3 years ago

Four senior FDA leaders forged close ties with Biogen well ahead of Aduhelm's approval. Now they've left FDA

3 years ago

FDA simplifies Covid-19 bivalent vaccination process ahead of June adcomm

3 years ago

Avenue touts progress with FDA on embattled pain candidate after two CRLs, failed adcomm

3 years ago

Adcomm unanimously recommends Entasis' bacterial pneumonia candidate for resistant infections

3 years ago

Gamida Cell wins FDA approval for new cord blood-based therapy for cancer patients

3 years ago

Abortion pill can't just 'snap back' to pre-2016, FDA's Woodcock tells SCOTUS

3 years ago

FDA adcomm votes in favor of first drug for agitation associated with Alzheimer's dementia

3 years ago

Troubled Reykjavik plant lands Alvotech a second CRL for its potential Humira biosimilar

3 years ago

FDA rejects Lilly's ulcerative colitis drug mirikizumab over manufacturing issues

3 years ago

Appeals court temporarily keeps abortion pill on the market, but FDA may have to revert to older restrictions

3 years ago

Ghana approves Oxford University's malaria vaccine for children

3 years ago

FDA may need to 'get creative' if abortion pill approval pulled this week

3 years ago

Biotech execs say mifepristone decision would 'upend' FDA's new drug application process

3 years ago

First page Previous page 56 57 585960 61 62 Next page Last page