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FDA Issues Early Alert on Erbe Flexible Cryoprobes

[ Price : $8.95]

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that som...

Hims & Hers Super Bowl Ad Hit

[ Price : $8.95]

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement act...

FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

[ Price : $8.95]

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are li...

Updated Guidance Clarifies Biosimilar Development Requirements

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FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

Incyte Gets Complete Response Over Catalent Inspection Issues

[ Price : $8.95]

FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspectio...

Group urges Pfizer to Retract Threat on Drug Supplies

[ Price : $8.95]

Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by C...

Roche Breast Cancer Drug Misses Endpoint in Late-Stage Trial

[ Price : $8.95]

Roche reports that its investigational breast cancer drug giredestrant failed to significantly extend progression-free survival in...

FDA Meets with States to Advance Canada Importation Plan

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FDA says it recently held a meeting with several states to discuss implementation of a program that would allow the importation of...

Xenon Reports Positive Phase 3 Data for Epilepsy Drug

[ Price : $8.95]

Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in p...

Ipsen Withdraws Tazverik Over Safety Data

[ Price : $8.95]

Ipsen voluntarily withdraws Tazverik (tazemetostat) from the market based on emerging data from the ongoing Phase 1b/3 SYMPHONY-1 ...