March 22, 2024
Bringing more drug competition to the market is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. In 2017, […]
March 22, 2024
The European Medicines Agency (EMA) has granted a marketing authorization to Novartis Europharm for Fabhalta (iptacopan) for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) who have […]
March 22, 2024
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of […]
March 22, 2024
The Prescription Drug User Fee Act of 1992 (PDUFA), Biosimilar User Fee Act of 2012 (BsUFA), and Generic Drug User Fee Amendments of 2012 (GDUFA) authorize […]
March 22, 2024
TOPLINE: Anti-osteoporosis medications reduce fracture risk similarly, regardless of whether patients are younger or older than 70 years. METHODOLOGY: Investigators conducted the study as part of […]
March 22, 2024
TOPLINE: Despite best efforts, non-clinical practice staff do not appear to benefit from educational interventions aimed at improving the timeliness of shingles diagnosis (ie, within 72-144 […]
March 22, 2024
Patients with cancer receiving chemotherapeutics may develop diarrhea, which can be highly distressing. In a recent journal article, oncologist Marcus Hentrich, MD, and gastroenterologist Volker Penndorf, […]
March 22, 2024
FRANKFURT (Reuters) -Germany’s public health insurance scheme can cover certain patients with a risk of heart disease or strokes to take the weight-loss Wegovy drug, a […]
March 22, 2024
A new study confirmed an elevated risk for myelodysplastic syndrome or acute myeloid leukemia (MDS/AML) after poly(ADP-ribose) polymerase (PARP) inhibitor therapy in women with ovarian cancer […]