News
An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
FEATURED STORIES
As antibody-drug conjugates advance and move into earlier lines of treatment, drug developers have to build gentler therapies that don’t just extend survival but improve it.
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Graphite Bio is discontinuing the development of nulabeglogene autogedtemcel (nula-cel), its lead asset, and shaving off about 50% of its workforce.
One day after revealing a restructuring initiative, Jounce Therapeutics announced it plans to merge its business in an all-stock deal with clinical-stage biotech Redx Pharma.
With more than $600 million on the line, AbbVie is expanding its strategic collaboration with Capsida Biotherapeutics to advance three gene therapy programs for eye diseases.
Some consider a candidate’s alma mater to be the most important factor in the hiring process. But how much does a life science candidate’s alma mater really matter? In short–it depends.
New York City employers who use Artificial Intelligence (AI) tools in hiring will soon be subject to new regulations requiring them to notify candidates when using the technology.
Life Edit’s technology will combine with Moderna’s mRNA platform to develop in vivo gene editing therapeutics against thus far undisclosed challenging genetic diseases.
PTC Therapeutics reported Q4 and full-year 2022 results Tuesday ahead of a pivotal 2023 featuring three late-stage readouts in registration-directed trials.
After overcoming a clinical hold, Astellas presented preliminary safety and efficacy data from the Phase I/II FORTIS trial of AT845 in late-onset Pompe disease at the 19th Annual WORLDSymposium 2023.
The FDA accepted the BLA for and granted Pfizer’s maternal RSV vaccine candidate priority review.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.