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Armed Cell Therapeutics, chaired by former Galapagos CEO Paul Stoffels, has assumed control of cell therapies the company - now known as Lakefront Biotherapeutics - divested in a strategic overhaul.
A revamped regulatory framework may give investors less of a "guessing game" as they weigh chances for drug approvals, one analyst said.
On October 28, 2026, the U.S. Food and Drug Administration, in partnership with the Reagan-Udall Foundation for the FDA, will convene a hybrid public meeting to seek input related to the FDA’s Rare Di
This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Inte
This half-day virtual workshop features FDA expert presentations and audience Q&A on bioequivalence (BE) approaches for topical and transdermal generic drug products.
Part of a wave of young biotechs employing AI to accelerate research, the company claimed in regulatory filings that its approach has the potential to "disrupt legacy drug discovery paradigms."
This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in t
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health
In a first, a subcutaneously administered RNA interference medicine crossed into the brain and plummeted levels of a protein implicated in the disease.
Rare Disease Regulatory Framework
The U.S. Food and Drug Administration, a division within the U.S. Department of Health and Human Services (HHS), today announced the Rare Disease Framework Initiative to reimagine the development of d
Wall Street analysts believe Verastem's drug to now be "competitive" in what's quickly become one of the most active and crowded areas of oncology research.
Prosecutors say the company filled unnecessary prescriptions that fueled the opioid epidemic. A spokesperson for CVS said the company admitted to no wrongdoing and "strongly disagreed" with the case's
A 6% sell-off in J&J shares was viewed by one analyst as emblematic of broader market volatility. Elsewhere, Gilead is collaborating with Vir and a biotech's bid for a product expansion fell short
Discover why flow paths, tubing and connectors may limit your bioprocess performance
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