News

After a sluggish 2025, biotech IPOs have roared back to life. Fueled by resilient stock performances and improving market sentiment, the total number of public debuts so far this year has already eclipsed 2025’s total.
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.
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FDA
The new FDA-approved manufacturing process for Kite’s CAR-T cell therapy Yescarta will allow a 14-day turnaround compared to 16 days, the company announced on Tuesday.
The investment in Illinois-based Cour Pharmaceuticals had participation from Bristol Myers Squibb, Pfizer Breakthrough Growth Initiatives and Roche Ventures.
Lori, Greg and Tyler discuss last week’s ⁠call for a class-wide box warning⁠ on all commercial CAR T therapies, while investigations are ongoing into ⁠cases of secondary malignancies⁠. How do we approach this ⁠balancing act⁠ of treatment and side effects?
The Swiss pharma’s fourth-quarter sales fell short of analysts’ estimates on Wednesday, as the company said it dropped a late-stage blood cancer hopeful after failing a Phase III study.
The Centers for Medicare and Medicaid Services will enter talks with manufacturers to come up with a pricing and rebate scheme that will tie the gene therapies’ cost with their effectiveness.
Defender Pharmaceuticals on Tuesday did not reveal the reasons for the regulator’s rejection of its nasal gel version of scopolamine. The company is seeking a meeting with the FDA to “understand the issues.”
Here are the top companies on BioSpace with internship opportunities for graduate students.
Ascidian Therapeutics, a member of BioSpace’s NextGen Class of 2024, on Monday announced it received IND clearance from the FDA and was granted Fast Track designation for ACDN-01.
The FDA has granted Priority Review for AstraZeneca and Daiichi Sankyo’s supplemental BLA for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors.
After Tamar Bresge was diagnosed with retinitis pigmentosa at age 15, her entrepreneurial father made it his mission to help find a cure.