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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 complaint alleges the agencies made an error under the Administrative Procedure Act, violating the Food Drug and Cosmetics Act by failing to approve Lumryz.
Daiichi-Sankyo and AstraZeneca’s sBLA for HER2 directed Enhertu accepted by FDA. Novartis gets BLA acceptance for MS biosimilar. HOOKIPA’s IND for prostate cancer immunotherapy candidate accepted
A study published this month in Science discusses data that may support a devious alter ego of T-cells present within colorectal cancers that appear to inhibit and promote tumor progression.
The announcement signals that the WHO now views the outbreak as significant enough that a coordinated global response is necessary to control it.
Replay features next-generation genomic medicine technologies in its portfolio to address the needs of diseases that have large unmet needs.
FDA Weekly Review looks at the FDA’s actions related to drug approvals, IND approvals, designations and more. Here’s a look at what happened this week.
VistaGenTherapeutics announced data showing that its nasal spray candidate for anxiety, depression and other central nervous system disorders, fell short of its primary endpoint.
“The applications for mRNA are quite broad, because, basically, you are giving information to a cell to make any protein you want,” CureVac CFO Pierre Kemula told BioSpace.
Maxvax and Luzhu are raising funds to move their respective research and development programs for recombinant herpes zoster vaccine candidates and new adjuvant products.
Researchers evaluate just how well therapeutic antibodies and antivirals work against Omicron, Vaxart’s oral vaccine shows early promise and hypertension doubles the risk of hospitalization.