The Department of Justice announced that six Dallas, Texas-area pharmacy owners and marketers were charged for their role in a $14 million healthcare fraud scheme involving illegal kickbacks and...
Eli Lilly and Company recently announced the FDA approved Retevmo (selpercatinib), the a therapy specifically for the treatment of metastatic rearranged during transfection (RET) driven lung and...
FDA recently issued an Emergency Use Authorization (EUA) for Abbott’s SARS-CoV-2 IgG lab-based serology blood test on the Alinity i system.
For more coronavirus updates, visit...
The Department of Justice announced that Apotex Corp, a generic pharmaceutical company, agreed to pay a $24.1 million criminal penalty for the role it played in antitrust violations from May 2013 to...
The National Institutes of Health (NIH) and Foundation for the NIH recently announced it is joining forces with more than a dozen biopharmaceutical companies to boost COVID-19 drug...
With COVID-19 continuously spreading throughout the US, the FDA took two major actions to address the virus and enhance its ongoing commitment to the public, according to a recent press release.
For...
Globally, companies manufacturing gene therapy, cell therapy, and other regenerative medicines raised nearly $10 billion in 2019, the second-highest year on record, according to a recent analysis from...
Patients will now have access to a cheaper version of the drug at the center of a recent price gouging case. In an announcement on Feb. 28, the FDA reported that it has approved the first generic drug...
Esperion recently announced that the FDA approved Nexletol an LDL-cholesterol lowering medicine, boosting access to medicine for patients with familial hypercholesterolemia or atherosclerotic...
Biotechnology and pharmaceutical stakeholders largely supported guidance from the FDA on patient-focused drug development, but some sought some clarification about FDA decision-making.
The agency held...
The Food and Drug Administration issued updates to its policy on prioritization of generic drug applications to make better use of the agency's limited resources.
The Manual of Policies and...
The Federal Trade Commission and the New York Attorney General Letitia James filed a complaint in federal court against Vyera Pharmaceuticals, Martin Shkreli and Kevin Mulleady, seeking to ban the...
A Health Affairs blog post on Tuesday made the argument to invest in vaccine infrastructure and education to “turn the tide” on vaccine-preventable diseases, breaking it down by problem...
Study sponsors will be subject to a new requirement for pediatric investigations beginning August 18, with new Food and Drug Administration draft guidance offering transitional information.
The...
A new study published Tuesday in JAMA suggests that the evolution of drugs and biologics’ regulatory approval programs at the US Food and Drug Administration has resulted in a system that...
As the Food and Drug Administration looks to reorganize its Office of New Drugs (OND) this year, drugmakers and industry trade groups have recommendations to inform OND’s...
The state of California is set to propose, as early as this spring, two initiatives to establish a single market for drug pricing within the state and a new contracting program for generic...
The pharmaceutical industry could lose $1 trillion in overall revenue and still remain as one of the most lucrative industries in the country, according to research conducted in partnership between...
In October 2018, the Trump administration proposed an international reference pricing model to reduce the federal government's spending on prescription drugs.
The International Pricing Index (IPI)...
