May 17, 2024
The bolus thrombolytic agent, tenecteplase, narrowly failed to show non-inferiority to alteplase in the TASTE clinical trial within 4.5 hours of symptom onset selected by perfusion […]
May 17, 2024
Lower urinary tract symptoms (LUTS) were significantly associated with lower scores on measures of cognitive impairment in older adults, based on data from approximately 10,000 individuals. […]
May 16, 2024
The US Food and Drug Administration has granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen) for extensive-stage small cell lung cancer (SCLC) with disease progression on or […]
May 16, 2024
Adding atezolizumab to chemotherapy in patients with anti–programmed death ligand 1 (PD-L1)–positive triple-negative breast cancer (TNBC) who have relapsed within 12 months of their last curative […]
May 16, 2024
These frequently asked questions have been developed for the CDER Small Business and Industry Assistance Web site to help small pharmaceutical businesses understand the regulatory process […]
May 16, 2024
On May 16, 2024, the Food and Drug Administration granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with […]
May 16, 2024
Compounders sometimes produce drugs using bulk drug substances, also known as active pharmaceutical ingredients. For example, when a patient has an allergy to an ingredient in […]
May 16, 2024
Updated August 21, 2023 FDA is evaluating bulk drug substances that were nominated for inclusion on the 503B bulks list, proceeding case by case, under the […]
May 16, 2024
VENICE, Italy — Obesity as defined by adiposity measures corresponds to a lower body mass index (BMI) cutoff (≥ 27) in men and women of middle […]