In an 8-4 vote, the FDA’s Oncologic Drugs Advisory Committee Roster voted against the benefit-risk profile of Secura Bio’s P13K inhibitor Copiktra (duvelisib).
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Seagen and LAVA Therapeutics inked a licensing deal for LAVA’s Gammabody platform for solid tumors, which can potentially exceed $700 million.
With Emma Walmsley as GSK’s chief executive, Julie Brown’s appointment also creates a rare, all-female top management at a blue-chip British company and a global pharma major.
September is Childhood Cancer Awareness Month, which sheds light on the need for new developments in pediatric oncology. For American children, the number one cause of death by disease is cancer. Pediatric gliomas, the most common type of brain tumor in children, are a critical area of focus for oncology research.
The FDA might only have two PDUFA dates on the calendar this week, but all eyes in the neurodegenerative disease community will be on the first one: Amylyx’s AMX0035 for ALS.
Recent studies have shown that patients with weakened immune systems — which enables the virus that causes COVID-19 to remain longer in the body, copy itself, and continually change — may enable the development of new, slightly different versions of the virus (variants).
Pfizer Inc. and its German partner BioNTech on Monday sought the U.S. Food and Drug Administration’s authorization for an Omicron-tailored COVID-19 vaccine booster for children aged 5 through 11 years.
The French drugmaker is in talks with a potential partner on producing an updated version of its COVID-19 vaccine that targets new variants of the disease, sending its shares up. Valneva has struggled to bring its COVID-19 vaccine to market to compete with rival products from drugmakers such as AstraZeneca, Moderna and BioNTech/Pfizer.
Company CEO Albert Bourla has received four doses of the COVID vaccine developed by Pfizer and its German partner BioNTech but said he has not yet taken the new bivalent booster.
How the healthcare industry can better reach hispanic communities.