Hepcludex is now the first and only approved treatment for HDV patients in the US, marking a significant milestone for HDV ...
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.
By Christy Santhosh May 28 (Reuters) - The U.S. FDA's advisory panel will meet and then vote on Thursday on whether COVID-19 ...
New research suggests a first-of-its-kind drug for hepatitis B may let some patients stop treatment without showing signs of ...
Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health.
Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...
The CD123-directed antibody and alkylating agent conjugate led to complete remission or clinical complete remission in nearly ...
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide ...
The FDA made waves with its recent announcement that a single well-controlled Phase 3 study would suffice for a drug submission, replacing the previous standard of two pivotal studies. This past week, ...
ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. U.S. inspectors have uncovered new and dangerous breakdowns ...
ProPublica is a nonprofit newsroom that investigates abuses of power. Sign up to receive our biggest stories as soon as they’re published. These highlights were written by the reporters and editors ...
The U.S. Food and Drug Administration is shuffling its top drug and biologics regulators, days after the departure of former commissioner Marty Makary.