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J&J sBLA for Tremfya in Ulcerative Colitis

[ Price : $8.95]

Johnson & Johnson files a supplemental BLA for Tremfya (guselkumab) for treating adults with moderately to severely active ulcerat...

Panel Backs Lumisight Breast Surgical Imaging

[ Price : $8.95]

An FDA advisory committee votes 16-2 in support of approving a Lumicell NDA for Lumisight (pegulicianine), an optical imaging agen...

Getinge Vasoview Hemopro 3 Cleared

[ Price : $8.95]

FDA clears a Getinge 510(k) for the Vasoview Hemopro 3, a third-generation endoscopic vessel harvesting device.

Wegovy OKd for Reducing Cardiovascular Death

[ Price : $8.95]

FDA approves Novo Nordisks weight loss drug Wegovy (semaglutide) injection for reducing the risk of cardiovascular death, heart at...

FDA Delays Lilly Alzheimers Drug for Panel Review

[ Price : $8.95]

FDA pushes back its review decision on Eli Lillys experimental Alzheimers drug donanemab by requiring an advisory committee to dis...

Amylyx Mulls Withdrawing ALS Drug

[ Price : $8.95]

Amylyx Pharmaceuticals considers withdrawing its amyotrophic lateral sclerosis drug Relyvrio (sodium phenylbutyrate and taurursodi...

Lilly Requests EUA Revocation for Covid Combo

[ Price : $8.95]

Federal Register notice: FDA revokes an Eli Lilly emergency use authorization for bamlanivimab and etesevimab administered togethe...

KVK Paying $3.5 Million in Guilty Plea

[ Price : $8.95]

KVK Research and KVK Tech of Bucks County, PA, plead guilty to introducing adulterated drugs into interstate commerce and agree to...

Positive Phase 1 Data on New Novo Weight-Loss Drug

[ Price : $8.95]

Novo Nordisk says its experimental weight-loss pill amycretin achieved a 13.1% weight loss in participants in a Phase 1 trial.

Accelerated Approval for Brukinsa for Some Lymphomas

[ Price : $8.95]

FDA grants accelerated approval for BeiGenes Brukinsa used with Genentechs Gazyva to treat some follicular lymphomas.