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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.
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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.
After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
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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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The European Commission upheld exclusive marketing protection in Europe for Biogen’s multiple sclerosis therapy Tecfidera until February 3, 2025, staving off generic competition.
Iovance’s lifileucel for advanced melanoma and Madrigal’s resmetirom for nonalcoholic steatohepatitis are just a couple of the key decisions on the FDA’s docket this quarter.
Companies and patients alike are questioning the Federal Trade Commission’s challenges to various biopharma agreements.
Shares of several biopharma companies in the CAR-T space dropped after the FDA’s announcement, but analysts remain optimistic about the sector’s future.
Carl Icahn is seeking to get rid of “legacy conflicted directors” on Illumina’s board following the announcement that GRAIL will be divested after a drawn out antitrust battle with regulators.
Israel-based cancer immunotherapy company Compugen will receive $60 million upfront from Gilead for the license to its antibody, which blocks the interaction between the IL-18 binding protein and IL-18.
The combination of Jemperli and chemotherapy followed by Zejula improved progression-free survival in a late-stage study of patients with advanced or recurrent endometrial cancer.
While the candidate was effective in Phase III results, Point’s stock price fell following the announcement.
A GLP-1-based drug from Structure Therapeutics shows clinical promise but not enough for some on Wall Street.
BMS will halt a trial investigating the Opdulag combination in colorectal cancer after determining that it would not hit its primary endpoint.