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BioCryst sNDA Expands Patient Population

[ Price : $8.95]

FDA approves a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for tr...

CBER CY 2021 Guidance Agenda

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CBER says it plans to issue 14 guidances in three categories in the current calendar year.

FDA OKs Galdermas Restylan Defyne for Chin Work

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FDA approves Galdermas Restylan Defyne for the augmentation and correction of mild to moderate chin retrusion for adults over the ...

FDA Clears 3D Manufacturers Cervical Interbody Device

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FDA clears an NGMedical 510(k) for its 3D-manufactured titanium cervical interbody BEE cage implant.

FDA Approves Durect Posimir for Surgical Pain

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FDA approves a Durect NDA for Posimir (bupivacaine solution) for infiltration use in adults for administration into the subacromia...

Workshop to Tackle Nitrosamine Impurities in Drugs

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FDA plans a 3/29-30 public workshop on Nitrosamines as Impurities in Drugs; Health Risk Assessment and Mitigation.

Safety-Related Gocovri Labeling Changes Approved

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FDA releases safety-related labeling changes for Adamas Gocovri.

BioCryst sNDA Expands Patient Population

[ Price : $8.95]

FDA approves a BioCryst Pharmaceuticals supplemental NDA for Rapivab (peramivir injection) expanding the patient population for tr...

Doctors Irked by Virtual Detailing in Pandemic: Indegene

[ Price : $8.95]

Drug consulting firm Indegene says many doctors are voicing concerns about their virtual interactions with drug company representa...

2 Observations on Hopkinton Drug FDA-483

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FDA releases an FDA-483 with two observations issued following an inspection at Hopkinton Drug, a producer of non-sterile drug pro...