News
FDA’s rare disease decisions are strongest when the patient community has a voice in advisory committee decisions.
FEATURED STORIES
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
Even as FDA approvals for biologic therapies fell in the first half of 2026, regulatory experts are optimistic about a turnaround in the rare disease space after the departure of key leaders at the agency. Still, there will continue to be tension between science and politics.
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
A combination study of CG Oncology’s oncolytic immunotherapy and a checkpoint inhibitor is showing promise.
Legend Biotech and J&J, Adicet Bio, Curis and Immutep present optimistic early and mid-stage results at ASCO.
Ibrance, a first-line treatment for ER+, HER2 - metastatic breast cancer, did not improve the overall survival rate in patients. Read on to know more.
Data presented at the ASCO meeting this weekend show that treatment with Enhertu demonstrated a 49% improvement in median overall survival by more than six months.
The early data demonstrated a favorable safety profile and encouraging indications of clinical activity. BNT122 is being developed in multiple solid tumor indications.
The study revealed that Yescarta was both safe and effective in adult patients regardless of race and ethnicity.
Gilead Sciences shared what seemed to be good news regarding Trodelvy in HR+/HER2- breast cancer at the 2022 American Society of Clinical Oncology’s annual meeting.
Well-known for its neurological drug development programs, Alkermes has firmly planted its flag as an oncology company at ASCO. Alkermes Head of Oncology Jessicca Rege spoke with BioSpace.
Primary seven-year data from Janssen’s (Johnson & Johnson) Phase III trial of Imbruvica (ibrutinib) in lymphoma demonstrated positive survival outcomes.
It was a busy, busy week for clinical trial news and updates, largely driven by the annual ASCO meeting taking place June 3-7 in Chicago.