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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.
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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
The Phase III ADvocate 1 and 2 studies on lebrikizumab showed that eight out of 10 patients with atopic dermatitis maintained skin clearance in the 12 months they had been under treatment.
Novartis has fallen victim to a cyberattack. The Swiss pharma giant’s data was hijacked by a well-known online extortion ring dubbed Industrial Spy.
BioSpace caught up with Tara Frenkl and Nelson Ambrogio ahead of ASCO to discuss Bayer’s goal of becoming a top 10 oncology company by 2030.
CEL-SCI Corporation, Jazz Pharmaceuticals, CARsgen and Ascentage Pharma presented clinical trial data at the American Society of Clinical Oncology 2022 Annual Meeting.
Sernova shared positive Phase I/II data from an ongoing clinical study of its implantable Cell Pouch device that showed evidence of in vivo active insulin production.
Results of a Phase II/III study showed that patients who were given Tafinlar plus Mekinist saw an overall response rate of 47% vs. 11% for those who received standard chemotherapy only.
Johnson & Johnson and Emergent BioSolutions are accusing each other of breaching their COVID-19 vaccine supply agreement.
The Phase II/III Aria Study was unsuccessful in achieving statistical significance on the primary endpoint or any secondary objectives, according to Praxis.
The combination of Opdivo plus Yervoy in addition to chemotherapy demonstrated additional benefits in patient populations who usually have poor prognoses.
Data presented in bladder and pancreatic cancer at ASCO underscore the company’s vision of using NK cells and T cells to target difficult-to-treat cancers.