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J&J Reports Favorable TAR-200 Clinical Data

[ Price : $8.95]

A Phase 2b clinical study evaluating Johnson & Johnsons investigational TAR-200 monotherapy in nonmuscle-invasive bladder cancer p...

GlycoMimetics Phase 3 Leukemia Study Fails

[ Price : $8.95]

GlycoMimetics says its Phase 3 study of uproleselan plus chemotherapy in acute myeloid leukemia patients did not achieve a statist...

REMS Logic Model Draft Guidance

[ Price : $8.95]

FDA posts a draft guidance entitled REMS Logic Model: A Framework to Link Program Design With Assessment" to help applicants with ...

12 No-Longer-Marketed ANDAs Withdrawn

[ Price : $8.95]

Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified the agency that they were...

Test Emergency Policies Under Sec. 564 Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Consideration of Enforcement Policies for Tests During a Se...

FDA Clears ZygoFix Spinal Fusion Alternative

[ Price : $8.95]

FDA clears a ZygoFix 510(k) for its zLOCK Lumbar Facet Fixation System an implant that adapts to the joint's anatomy during insert...

Lyric Hearing Aid Cleared for Self Replacement

[ Price : $8.95]

FDA clears a Phonak 510(k) for its Phonak Lyric hearing aid and a self-replacement option to reduce office visits.

FDA Debars Runsdorg Over Cough Syrup

[ Price : $8.95]

Federal Register notice: FDA issues an order permanently debarring Adam Paul Runsdorf over his felony conviction for conspiring to...

CDER Launches Quantitative Medicine Center

[ Price : $8.95]

CDER launches a new Quantitative Medicine Center of Excellence to help streamline and accelerate drug development.

Veterinary Pharmaceutical Development Draft Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a veterinary-use draft guidance entitled #290 (VICH GL61) Pharmaceutical Development....