Latest FDA News
Pharmaceutical
The US Senate has confirmed President Donald Trump’s nominees to lead two of the country’s top health agencies, approving surgeon Marty Makary as Commissioner of the Food and Drug Administration and economist and physician Jay Bhattacharya as director of the National Institutes of Health. 27 March 2025
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A clinical-stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with hematologic malignancies and solid tumors.
Latest News & Features of interest to FDA
Pharmaceutical
Research funded by the US Food and Drug Administration suggests that people who view drug adverts are more likely to respond to a claim about a product’s popularity than its efficacy. 18 March 2019
Generics
Research shows some 79% of the American public view the cost of prescription drugs as unreasonable, and lawmakers and regulators are increasingly convinced the industry charges too much for its products. 8 March 2019
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement outlining his agency’s efforts to stop the illegal importation of drugs and control the drug supply chain. The agency will also seek more more focused New Drug Applications (NDA) for opioid products. 12 February 2019
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has issued a statement outlining steps the agency is taking to reform the process for public warnings on product recalls. 8 February 2019
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has provided an update on the agency’s new actions under the Digital Health Precertification (Pre-Cert) Program. 8 January 2019
Pharmaceutical
Following a review of fluoroquinolone antibiotics, the US Food and Drug Administration has issued a statement regarding an association with a rare but serious side effect. 21 December 2018
Pharmaceutical
The US Food and Drug Administration has issued new guidance related to clinical trial endpoints in oncology, providing recommendations for applicants seeking approval for novel therapies. 20 December 2018
Generics
The US Food and Drug Administration has said it is withdrawing a proposed rule which would have allowed generic drugmakers to independently update and distribute new safety information in drug labels. 14 December 2018
Pharmaceutical
The US Food and Drug Administration has issued a statement detailing a new strategic framework to promote the use of real-world evidence (RWE) and real-world data (RWD) in the drug development process. 7 December 2018
Pharmaceutical
Drug-making is sometimes pictured as one of the last surviving “traditional” industries, successfully resisting waves of change that have overtaken other businesses. 5 December 2018
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