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FDA Approves Coherus Pegfilgrastim Autoinjector

[ Price : $8.95]

FDA approves a Coherus BioSciences BLA for single-dose, prefilled autoinjector presentation of its Udenyca (pegfilgrastim-cbqv), ...

FDA Requires More Mammography Reporting

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FDA updates its mammography facility regulations to add new patient communication and oversight requirements.

FDA, EMA Parallel Scientific Advice is Effective: Study

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FDA and European Medicines Agency staff describe the benefits seen in their joint Parallel Scientific Advice program.

Lilly Drops Solanezumab on Negative Results

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Lilly says it is terminating the clinical development of solanezumab for preclinical Alzheimers disease after it failed to meet th...

How Can FDA Combat Medical Misinformation?

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FDA commissioner Robert Califf says in a Stat News interview that FDA is looking for ways to improve and expand its efforts to com...

FDA Seeks $372 Million (10%) Budget Boost for FY 2024

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FDAs seeks a $372 million (10%) boost and a $150 million increase in user fees in its fiscal year 2024 budget proposal.

AstraZeneca Tagrisso Data on Improved Overall Survival

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AstraZeneca says data from its ADAURA Phase 3 trial showed that Tagrisso (osimertinib) demonstrated a statistically significant an...

Former Stimwave CEO Indicted

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The Justice Department says the former CEO of Stimwave has been indicted for healthcare fraud in creating and marketing a non-func...

FDA Approves Amphastar Naloxone Nasal Spray

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FDA approves an Amphastar NDA for naloxone nasal spray for emergency treatment of an opioid overdose.

Shuren Addresses Firms Criticism as Misinformation

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CDRH director Jeff Shuren takes the unusual step of addressing a companys criticism directed at his Centers alleged delay in grant...