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E-cig Users More Susceptible to Covid: Representative

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Rep. Raja Krishnamoorthi says science has demonstrated that adolescent vapers are at a higher risk of contracting Covid-19 and thu...

Becton, Dickinson Recalls ChloraPrep Applicators

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Becton, Dickinson recalls its ChloraPrep 3 mL applicator due to possible fungal contamination.

FDA Challenges Remestemcell-L Data

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FDA medical reviewers ask the Oncologic Drugs Advisory Committee to discuss whether Mesoblast has demonstrated that its remestemce...

Disappointing Etrolizumab Phase 3 Results

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Genentech says its etrolizumab failed to meet Phase 3 endpoints in patients with ulcerative colitis.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Taka USA and Soluciones Cosmeticas.

FDA OKs Intravenous Opioid for Pain

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FDA approves a Trevena NDA for Olinvyk (oliceridine), an opioid agonist for managing moderate to severe acute pain in adults.

Guide on BIMO Technical Conformance

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FDA makes available a guidance entitled Bioresearch Monitoring Technical Conformance Guide.

Panel to Discuss Glaxo sNDA for COPD

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Federal Register notice: FDA announces an 8/31 online Pulmonary-Allergy Drugs Advisory Committee meeting.

Guide on Therapeutic Protein Drug-Drug Interactions

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Federal Register notice: FDA makes available a draft guidance entitled Drug-Drug Interaction Assessment for Therapeutic Proteins. ...

Guide on NDA/ANDA Marketing Status Notifications

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FDA makes available a guidance entitled Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic ...