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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 total of 52 mergers and acquisitions for the first half of 2026 reflects what analysts, industry watchers and executives are saying over and over: M&A is back.
At the BIO International Convention in San Diego, attendees marked the 50th anniversary of original biotech Genentech, reflecting on the immense challenges facing companies as China becomes a powerhouse innovator.
A recent FDA reversal sparked new hope for patients with Huntington’s disease. Flying under the radar, Skyhawk Therapeutics revealed 12-month functional data from a midstage trial of its own candidate showing improvements on a key disease measurement scale.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The FDA’s decision on Axsome Therapeutics’ Auvelity is based on positive results from a massive clinical program that covered over 1,100 patients with depression.
The regulatory path for companies developing drugs for rare diseases is often fraught with challenges. KemPharm CEO Travis Mickle discussed just some of these with BioSpace.
Curis announced that the FDA has allowed patient enrollment to resume in the monotherapy phase of its TakeAim Leukemia Phase I/II trial studying emavusertib.
This week’s Movers & Shakers include Arvinas, Inspire and Cambridge Isotope Laboratories all announcing new VP roles, and several others tap new C-suite executives.
A trial evaluating generic drugs against severe COVID-19 provided data showing their overall ineffectiveness, and COVID-19-related lawsuits continue to pile up.
CDC director Dr. Rochelle Walensky announced plans to launch a “reset” of the agency amid criticism over its handling of the COVID-19 pandemic and other public health threats.
South Korea-based Genuv Inc. announced the publication of a preclinical study showing the potential of Mekinist, approved by the FDA for melanoma, in Alzheimer’s disease.
Jazz Pharma is breaking new ground with its cannabidiol epilepsy treatment Epidiolex, taking the drug into a Phase III study in children and adolescents.
Genentech has partnered with Jemincare to develop and commercialize an asset that may provide new treatment options for people with advanced-stage prostate cancer.
Cases of monkeypox are growing at an alarming rate and Bavarian Nordic, the company that owns one of the two approved vaccines, may no longer be able to keep up.