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Serial biotech investor Kevin Tang previously unsuccessfully tried to buy Kezar Life Sciences via Concentra Biosciences, a biotech consolidation company owned by the venture capital firm he runs.
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The FDA has some big verdicts lined up in the second quarter, including one for a closely watched obesity drug that many anticipate will further intensify competition in weight loss.
Accumulating scientific evidence and industry interest from Eli Lilly, Altimmune and startup Baseline Therapeutics is driving further research on the therapeutic potential of GLP-1 receptor agonists in treating substance use disorders.
At the AD/PD annual meeting, Eisai presented real-world data suggesting Leqembi’s long-term safety and efficacy in people homozygous for APOE4, who were identified in trials as being at higher risk of brain bleeds while on the treatment. Alzheon, meanwhile, added further detail to trial results of its candidate in patients with the same genetic profile.
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While requests by government officials for anonymity when speaking to the media are nothing new, the practice attracts more scrutiny when the Department for Health and Human Services has pledged a commitment to “radical transparency.”
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Ipsen will withdraw Tazverik’s follicular lymphoma and epithelioid sarcoma indications as emerging data point to an elevated safety risk in patients undergoing treatment.
The FDA’s cancer advisors will discuss AstraZeneca’s application for the oral SERD camizestrant in breast cancer and the AKT inhibitor Truqap in prostate cancer.
Some biotechs that had seen regulatory setbacks under Center for Biologics Evaluation and Research director Vinay Prasad experienced stock bumps Monday morning. Under Prasad’s leadership, the rare disease space has suffered a series of controversial rejections.
Incyte is looking to expand the use of its PD-1 blocker Zynyz to treat non-small cell lung cancer. The FDA’s rejection did not flag problems with the drug’s efficacy or safety.
A “significant number of patients” could see a cure for multiple myeloma within the next two decades, one expert told BioSpace. Here are five therapies that could change the treatment paradigm.
FDA
Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle feathers in biopharma after presiding over the rejection of several rare disease therapies.
Servier will pick up Ojemda, which received FDA approval in 2024 to treat pediatric glioma. The drug clocked sales of $155 million for Day One Biopharmaceuticals in 2025.
TrumpRX and DTC sales may expand prescription drug access, but they will not solve the affordability crisis by themselves.
Zealand Pharma’s shares fell 32% in early morning trading Friday after its Roche-partnered asset petrelintide failed to meet investor expectations in a mid-stage clinical trial.
The FDA granted Johnson & Johnson a Commissioner’s National Priority Voucher in December 2025 after the combination of Darzalex and Tecvayli improved progression-free survival by 83%. The new approval is for second-line treatment of the blood cancer.