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The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agencyâs 79 total approvals, including supplemental nods.
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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 pharmasâ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian countryâs biotech industry.
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FDA Commissioner Marty Makary and CBER Director Vinay Prasad published an article in JAMA on Tuesday outlining the FDAâs priorities, including accelerating cures and the rapid deployment of artificial intelligence.
Instead of homing in on PSMAâcurrently the most validated target in prostate cancerâBMS and Philochem will instead collaborate on an early-stage molecule that binds to a novel marker called ACP3.
The companyâs intein-based technology is initially aimed at Stargardt disease, a type of macular degeneration.
The American Medical Association is also urging an âimmediate reversalâ of the HHS Secretaryâs decision to oust all 17 members of the CDCâs vaccine advisory board.
The layoffs will heavily affect Vertexâs operations in Rhode Island, where the biotech will consolidate three facilities into one.
Guggenheim Partners called Insmedâs Phase IIb readout âimpressive across the board,â with an efficacy profile that positions TPIP to be best-in-class in pulmonary arterial hypertension.
For $812 million, Novo Nordisk will enlist Deep Apple to discover and develop a non-incretin therapy for obesity, months after the Danish pharmaâs amylin efforts underwhelmed investors.
The deal is Lillyâs second obesity tie-up in a week, after sinking up to $870 million into an agreement with Camurus to develop long-acting versions of molecules against GLP-1 and other incretins.
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDCâs Advisory Committee on Immunization Practices; Metseraâs amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
Some companiesâ preferences for people who already have industry experience and the tough job market are among the hurdles those just starting out in biopharma must navigate, two recruitment experts told BioSpace.