The draft guidance for industry Drug Master Files describes how to prepare and submit DMFs. Here are some additional resources: Requesting a Pre-Assigned Application Number: To […]
TOPLINE: A new continuous multivariable allocation score, called the US candidate risk score (US-CRS), outperformed the current therapy-based 6-status system in rank ordering heart transplant candidates […]
(Reuters) – For Emmanuel Macron, more babies are vital to maintain France’s national vigour. Italy’s Georgia Meloni has made encouraging more Italian women to give birth […]
LAS VEGAS — The introduction of biosimilars has driven down the costs of originator biologics, but it isn’t clear whether those cost savings are being passed […]
Maria Maio wasn’t the only person in her workplace battling COVID-19 in early December 2023. But while everyone else she knows got better, she got long […]
TOPLINE: Cancer surgery poses an elevated risk for venous thromboembolism, which can vary depending on the type of cancer and the timing of surgery, a new […]
New observational data showed no significant difference in subsequent ischemic stroke with anticoagulation compared with antiplatelet therapy, although there was a nonsignificant trend toward a lower […]
The US Food and Drug Administration (FDA) has approved irinotecan liposome (Onivyde, Ipsen Biopharmaceuticals, Inc.) in combination with oxaliplatin, fluorouracil, and leucovorin for the first-line treatment […]
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