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BeiGene sNDA for Brukinsa in Lymphoma

[ Price : $8.95]

FDA accepts a BeiGene supplemental NDA for Brukinsa (zanubrutinib) in combination with obinutuzumab for treating adult patients wi...

Panel to Discuss Decongestant Phenylephrine

[ Price : $8.95]

Federal Register notice: FDA announces a 9/11-12 Nonprescription Drugs Advisory Committee meeting to discuss decongestant phenylep...

Lymphoma Trial Enrollment Paused After 7 Deaths

[ Price : $8.95]

ADC Therapeutics pauses new patient enrollment in the Phase 2 LOTIS-9 clinical trial evaluating Zynlonta (loncastuximab tesirine-l...

Praise for FDA Final PFDD Guidance

[ Price : $8.95]

Three stakeholders praise an FDA guidance on adding clinical outcome assessments to patient-focused drug development regulatory de...

Megadyne Recalls MEGA Patient Electrodes

[ Price : $8.95]

Megadyne recalls its MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes after receiving burn reports affecting pediatric a...

Innovative Manufacturing Workshop Positive Comments

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Two stakeholders respond positively to a recent FDA workshop on innovative drug manufacturing techniques.

No Higher Death Risk in Paclitaxel-Coated Devices: FDA

[ Price : $8.95]

FDA says it no longer sees the potential for excess mortality in paclitaxel-coated devices used to treat peripheral arterial disea...

Metabolism Inborn Errors Guidance

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FDA publishes a draft guidance recommending how to optimize and standardize dietary management in clinical trials of drugs to trea...

Info Collection on EUAs for Medical Products

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Emergency Use Authorization of Medical Prod...

More Study of Patient-Reported Frailty Needed: FDA

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CDER researchers say a five-item questionnaire they developed successfully used patient-reported data to evaluate frailty in multi...