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Guidance on Impaired Renal Function Pharmacokinetics

[ Price : $8.95]

FDA makes availabile a revised draft guidance on Pharmacokinetics in Patients with Impaired Renal Function Study Design, Data Ana...

Vaccine Companies Pledge Scientific, Ethical Rigor

[ Price : $8.95]

In a move to shore-up public confidence, nine companies developing Covid-19 vaccines have pledged to uphold scientific, regulatory...

Consistent Hedgehog Inhibitor Labeling Sought

[ Price : $8.95]

A Duke Medical School dermatology professor calls on FDA to require consistent safety labeling for all approved hedgehog inhibitor...

Suggestions on DTC Research

[ Price : $8.95]

Four drug companies suggest changes to a proposed FDA study of multiple indications in DTC television ads.

Athena Bioscience Pain Drug Approved

[ Price : $8.95]

FDA approves an Athena Bioscience NDA for Qdolo (tramadol hydrochloride) oral solution 5mg/1ml, an opioid agonist indicated in adu...

Natco Opposes Taiho Lonsurf Petition

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Natco Pharma asks FDA to deny all relief sought in a petition by Taiho Oncology seeking protection of Lonsurf (trifluridine/tipira...

FDA Wants Feedback on Device Premarket Tracker

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FDA solicits feedback on desired features in a new medical device premarket submission tracker it is building.

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes PT MegaSurya Mas and Calvin Scott and Co.

Breast Cancer Drug Combination Doesnt Work: FDA

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FDA cautions that a clinical study shows that Genentechs Tecentriq in combination with paclitaxel is not effective in treating mTN...

Genentechs Gavreto Approved for Lung Cancer

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FDA approves a Genentech NDA for Gavreto (pralsetinib) for treating adults with metastatic rearranged during transfection fusion-p...