FDA+ channel feed – Endpoints News

FDA+ channel feed

ICMRA to launch several regulatory pilot programs centered around manufacturing inspections

3 years ago

FDA slaps warning letter on Minnesota API facility after employee destroys cleaning log

3 years ago

FDA sidelines Paul Hudson's $3.7B MS drug after establishing link to liver damage

3 years ago

FDA's VRBPAC votes in favor of adapting the Covid-19 vaccine to the latest Omicron variant

3 years ago

Aurobindo Pharma receives warning letter from India's SEC following more FDA question marks

3 years ago

Axsome's long delayed depression drug is back up for label discussions at the FDA, triggering a big spike in the share price

3 years ago

Spero’s UTI candidate gets the CRL hammer as the company falls into penny stock status

3 years ago

As court case looms, Bristol Myers touts label expansion for Breyanzi

3 years ago

State battles over mifepristone access could tie the FDA to any post-Roe crossroads

3 years ago

FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation

3 years ago

No stranger to gene therapy woes, Astellas runs into another safety-related clinical hold

3 years ago

Updating the Covid-19 vaccine: FDA offers a qualified thumbs-up ahead of adcomm

3 years ago

FDA unveils new draft guidance to help with oligonucleotide therapeutics development

3 years ago

Amryt Pharma submits a formal dispute resolution to the FDA over rejected skin disease drug

3 years ago

Pharma-friendly senator calls on FDA for a third time to show patent protections shouldn't be blamed for high drug prices

3 years ago

EMA signs off on 3 drugs recently rejected by FDA, including BioMarin's new hemophilia gene therapy

3 years ago

Alarmed by side effect, FDA slaps clinical hold on Sarepta's next-gen Duchenne drug

3 years ago

When will the FDA rescind a breakthrough designation? New draft guidance spells out the complicated details

3 years ago

AbbVie shells out $440M on two PRVs for label expansions of its blockbuster Rinvoq

3 years ago

FDA warns Mexican glycerin manufacturer for refusing an inspection

3 years ago

Fight over where to house ARPA-H still brews with House bill's passage

3 years ago

Congress lays out its demands for FDA in 2023 — on everything from machine learning to immunotherapies

3 years ago

Novartis broadens BRAF/MEK cancer combo use, winning tumor-agnostic approval in patients 6 and up

3 years ago

FDA+ roundup: Spring regulatory agenda looks to finish off Cures implementation; GAO digs into medical countermeasures

3 years ago

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