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Meeting on Drug Development for Vitiligo

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Federal Register notice: FDA announces a 3/30 public meeting entitled Patient-Focused Drug Development for Vitiligo.

Sentinel Surveillance System Workshop in April

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FDA announces a 4/20-21 workshop entitled The 12th Annual Sentinel Initiative Public Workshop.

Trevena Resubmits NDA for Pain Drug

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Trevena resubmits its NDA for oliceridine for managing moderate-to-severe acute pain.

Xtandi Wins on Overall Survival in PROSPER Trial

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Pfizer and Astellas Pharma report study data demonstrating a statistically significant improvement in overall survival in men with...

Latest FDA Warning Letter

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FDA releases its latest batch of Warning Letters that includes one medical product company Marco Pharma.

FDA, BrainStorm Cell Agree on Potential NurOwn Pathway

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FDA and BrainStorm Cell Therapeutics agree on a potential regulatory approval path for NurOwn to treat ALS.

LogicBio Therapeutics IND Clinical Hold

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FDA puts a clinical hold on LogicBio Therapeutics LB-001 IND being investigated to treat methylmalonic acidemia.

WLF Asks End to California Patent Settlement Law

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Washington Legal Foundation asks the 9th Circuit Court of Appeals to enjoin a California law that presumes most drug patent settle...

OPQ Looks at Five Years of Success

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The Office of Pharmaceutical Quality 2019 annual report looks at the progress made in the organizations five years of existence.

FDA Lifts Marker Therapeutics Trial Hold

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FDA lifts its clinical hold on a Marker Therapeutics trial of its novel MultiTAA T-cell therapy for some acute myeloid leukemia pa...