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The FDA’s priority review acceptance of BridgeBio’s BBP-418 is another step toward what William Blair previously dubbed a “diversified commercial portfolio.” It also adds to the rapidly building momentum in muscular dystrophy more broadly.
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From Eli Lilly’s David Ricks to Pfizer’s Albert Bourla, the top five highest paid CEOs made a combined $157.8 million in 2025.
Partners Summit Therapeutics and Akeso are expected to steal the show at the American Society of Clinical Oncology’s annual conference with data from their potential Keytruda rival, alongside Revolution Medicine’s groundbreaking pancreatic cancer candidate and other assets that could reshape patient care.
The tragic tale of TIGIT is well known. However, RIPK1, myc, STING and alpha-synuclein have also left a trail of failed clinical trials, canceled partnerships and sunk investments in their wake.
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The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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The biotech industry is facing what some consider the worst times since its inception. Several market analysts recently shared their thoughts.
Here’s a look at global biopharma company news stories including Rona Therapeutics, Genuine Bio and NEOsphere Bio.
The transaction, Ginkgo’s largest acquisition to date, is expected to close by the first quarter of 2023, subject to regulatory approval and other closing conditions.
FDA
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
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.