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Novartis will use a priority review voucher to expedite review of the treatment that could hit blockbuster status within two years of launching.
The FDA’s approval marks the first personalized treatment targeting susceptible FGFR genetic alterations for patients with metastatic bladder cancer.
Developing a Human Factors Validation Plan with Consideration for the Digital Health Marketplace
Sprout wanted the warning regarding alcohol to be completely removed but the FDA said it must remain, although with a caveat.
Pharma and biotech companies from Asia to Europe provide updates on business and clinical activities.
With the ever-rising concerns over the costs of various prescription medications, a report from consumer pharmaceutical watchdog group Institute for Clinical and Economic Review released a report questioning the potential pricing of two yet-to-be-approved peanut allergy treatments.
Representatives from five of the nation’s biggest pharmacy benefits manager companies faced members of Congress on Tuesday as lawmakers continue to press pharma players on the high costs of prescription drugs in the United States.
The agency approved Evenity on the basis of two Phase III clinical trials. The drug had been rejected in 2017 over safety concerns.
The distinct roles of these immune cells opens the possibility of new treatments for human inflammatory diseases
PhaseBio Pharmaceuticals, based in Malvern, Penn. and San Diego, announced that its antiplatelet drug PB2452 had received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA).
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