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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 agency’s 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 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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This target date is the latest development in a long series of setbacks that Acadia - and other pharma companies - have experienced getting Alzheimer’s treatments approved.
Biopharma and life sciences companies from across the globe provide updates on their businesses and pipelines.
Pfizer has launched a Phase II/III study to assess its oral antiviral Paxlovid in non-hospitalized symptomatic pediatric patients who are at risk for progression to serious disease.
Kriya forged an antibody discovery agreement with Twist to support the delivery of antibodies with AAV gene therapy in therapeutic oncology applications.
Shares of Adaptive are climbing this morning after the company announced a reorganization of priorities to spur future growth, including a workforce reduction of approximately 12%.
Akari announced that votucalis has potential as a treatment for pain and itch associated with conditions such as atopic dermatitis, psoriasis and neuropathic pain.
AbbVie and Alvotech have settled a case, granting Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023.
Biopharma companies are preparing to unveil new data for various oncology programs at the American Association for Cancer Research (AACR) Annual Meeting in New Orleans next month.
Solve FSHD exists to fund biotechnology and biopharmaceutical research and development efforts toward finding a treatment and cure for FSHD.
BioNTech announced an expansion on its collaboration with Regeneron to continue advancing mRNA technology and develop novel treatments for a variety of cancers.