News
Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
FEATURED STORIES
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
THE LATEST
As Vertex and CRISPR Therapeutics’ exa-cel and Verve Therapeutics’ VERVE-101 move forward, questions remain about possible drawbacks of such therapies.
The private placement from existing and new investors extends the company’s cash runway into the second half of 2026 and will help take two candidates for inflammatory bowel disease into the clinic in 2024.
For the second time in as many days, Merck has reported a Phase III failure for its blockbuster PD-1 inhibitor Keytruda, this time as a first-line treatment with Eisai’s Lenvima for cancer in the uterus lining.
Results from a Phase III trial showed the combination improves progression-free survival compared to chemotherapy when used as a first-line treatment in metastatic colorectal cancer.
A combination of Merck’s experimental anti-TIGIT antibody vibostolimab and anti-PD-1 drug Keytruda failed to hit its endpoints in a mid-stage non-small cell lung cancer study.
While almost half of multiple myeloma patients on linvoseltamab achieved a complete response or better, all experienced adverse events and 14 patients died due to treatment-emergent AEs.
In this episode, hear from senior leaders at Microsoft and IQVIA to get their take on how generative AI is impacting productivity, employee engagement and how to mitigate risks.
Five years ago, Kyowa Kirin set out to expand its North America operations, adding new employees and capabilities at a rapid pace. The Human Resources team ensures employee input is central to managing that growth and nurturing a culture to support it
Following a nine-month review, the Biden administration will issue a framework for the National Institutes of Health to implement so-called “march-in rights” under the Bayh-Dole Act of 1980.
The deal, announced late Wednesday, will provide AbbVie with access to Cerevel Therapeutics’ pipeline of clinical-stage and preclinical candidates for psychiatric and neurological diseases.