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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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Provention Bio entered a co-promotion agreement with Sanofi ahead of the possible November approval of teplizumab. If approved, the drug would be the first approved to modify T1D.
Adocia, Allecra Therapeutics and Aldeyra Therapeutics announced promising results in Type I Diabetes, urinary tract infections and retinal diseases.
While Biogen and Eisai’s recent lecanemab data breathed new life into the anti-amyloid approach, experts say combination therapies will likely play a significant role in treating Alzheimer’s disease.
Nested Therapeutics, a precision oncology company targeting previously undruggable cancer targets, closed on a $90 million Series A financing, bringing total financing to $125 million since its inception in 2021.
GSK reported Wednesday its checkpoint inhibitor Jemperli yielded positive data in non-small cell lung cancer, moving the monoclonal antibody potentially closer to the market in this indication.
TrialSpark and Sanofi announced a new partnership to expedite drug development for areas with high unmet needs by licensing or acquiring six mid-to-late-stage drug candidates.
Biohaven will focus on developing therapeutics that modulate the Kv7 Ion Channel for the treatment of neurological and neuropsychiatric diseases. The new entity launched with $257.8 million in cash.
OncoSec Medical Inc. announced Tuesday that it was laying off around 45% of its workforce to focus its resources on the development of its lead asset TAVO-EP.
Funding rounds this week saw money flow into innovative drug discovery and delivery platforms, while pharma powerhouse Pfizer wrapped up two high-value neuro deals.
Araris Biotech AG secured $24 million in financing to advance the development of its proprietary antibody-drug conjugate (ADC)-linker technology and drive its own ADC candidates into the clinic.