Pharmacy
News
Drug granted breakthrough designation for CTCL
The US Food and Drug Administration (FDA) has granted breakthrough therapy designation to mogamulizumab for the treatment of adults with cutaneous...
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FDA grants priority review to BLA for emicizumab
The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for emicizumab. The BLA is for...
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FDA approves new strengths of hemophilia therapy
The US Food and Drug Administration (FDA) has approved new product strengths for the factor VIII therapy simoctocog alfa (NUWIQ®). Simoctocog...
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Study: Reference pricing does reduce prescription costs
Reference pricing effectively encourages patients to spend significantly less on prescription drugs, according to research published in NEJM....
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Drug granted orphan designation for chemo-induced ototoxicity
The US Food and Drug Administration (FDA) has granted orphan drug designation to SENS-401 to be used for the prevention of platinum-induced...
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FDA grants drug orphan designation for AML
The US Food and Drug Administration (FDA) has granted orphan drug designation to SY-1425 for the treatment of acute myeloid leukemia (AML). SY-...
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Researchers compare world health authorities
A new study has revealed substantial differences between health authorities in different regions of the world. A pair of researchers compared 12...
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FDA approves inotuzumab ozogamicin for rel/ref ALL
The US Food and Drug Administration (FDA) has approved inotuzumab ozogamicin (Besponsa®) for the treatment of adults with relapsed or refractory B...
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Post-approval trials for accelerated drugs fall short
New research has revealed shortcomings of post-approval studies for drugs granted accelerated approval in the US. Researchers found that, for...
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Drug granted priority review, breakthrough designation for ECD
The US Food and Drug Administration (FDA) has granted priority review and breakthrough therapy designation to vemurafenib (Zelboraf®) as a...
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Company resubmits BLA for andexanet alfa
Portola Pharmaceuticals Inc.