October 28, 2024
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to PharmaTher citing deficiencies in the company’s abbreviated new drug application for […]
October 23, 2024
The US Food and Drug Administration (FDA) has placed a partial clinical hold on the phase 3 PRESERVE-003 trial of BNT316/ONC-392 (gotistobart, BioNTech and OncoC4) for […]
October 18, 2024
The US Food and Drug Administration (FDA) has approved zolbetuximab (Vyloy, Astellas Pharma) in combination with fluoropyrimidine and platinum-containing chemotherapy for the first-line treatment of locally […]
October 18, 2024
The US Food and Drug Administration (FDA) has approved foscarbidopa and foslevodopa (Vyalev, AbbVie), a solution of carbidopa and levodopa prodrugs for 24-hour continuous subcutaneous infusion, […]
October 18, 2024
Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for two vaccines: Fluad (surface antigen, inactivated, adjuvanted) and Flucelvax (surface antigen, inactivated, […]
October 18, 2024
Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Eltrombopag Viatris (eltrombopag), a generic medicine for the treatment of […]
October 18, 2024
The European Medicines Agency (EMA) has upheld an earlier recommendation to deny marketing authorization for Masitinib AB Science (masitinib), an oral treatment for amyotrophic lateral sclerosis […]
October 18, 2024
The European Medicines Agency has recommended granting marketing authorization for a new hybrid formulation of buprenorphine as a substitution treatment of opioid drug dependence. Buprenorphine Neuraxpharm […]
October 18, 2024
In its October 2024 meeting, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave the green light for Korjuny (catumaxomab, Lindis […]