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Regulators on both sides of the Atlantic are pushing for the withdrawal of the rare disease treatment that accounted for just 1% of Amgen’s 2025 revenue. Nevertheless, Amgen continues to defend the medicine, which was acquired in the $3.7 billion buyout of ChemoCentryx.
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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.
Early-stage financing rounds are on track to hit their lowest dollar value in years as funders continue to eschew risky investments, experts told BioSpace.
A mostly black box since emerging with more than a billion dollars in hand, Xaira Therapeutics is slowly pulling back the curtain, revealing plans to find partners and validate its pipeline.
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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.
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Studies of Relmada’s drug, esmethadone, showed the drug had lower human abuse potential when compared to ketamine. Here are the results of this study.
Like any field, there are upsides and downsides to working in biotech, and educating yourself can help you make an informed decision if you’re considering a career in this industry.
AstraZeneca and Sanofi secured accelerated authorization for respiratory syncytial virus (RSV) antibody nirsevimab from the European Medicines Agency.
Silence Therapeutics, Totus Medicines and Poseida Therapeutics all adjust as they welcome new members to their leadership teams.
Marinus Pharmaceuticals reported that its Phase III RAISE trial of IV ganaxolone for status epilepticus will be delayed, thanks to the pandemic.
Public health officials begin to think we’ve turned the corner on the pandemic as new global cases drop 21% last week, the third consecutive week numbers and deaths have declined.
The DSMB endorsed the use of mRNA-1345 for the Phase III ConquerRSV study following positive preliminary Phase II data that demonstrates the vaccine’s safety profile.
Shares of Kodiak Sciences plunged nearly 70% in premarket trading after its Phase II/III study of KSI-301 failed to demonstrate non-inferior visual acuity gains compared to Regeneron’s Eylea.
Veru’s enobosarm shows good proof of concept data even when 90% of patients have failed first-line therapies.
Robert LaCaze is taking over the reins of Mnemo Therapeutics with the goal of overcoming key challenges in CAR-T therapies and driving the company’s lead assets into the clinic.