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Adcetris Positive Lymphoma Data: Pfizer

[ Price : $8.95]

Pfizer plans to share with FDA favorable data from its Phase 3 study of the antibody-drug conjugate Adcetris (brentuximab vedotin)...

Lexicon Refiling NDA for Sotagliflozin in Diabetes

[ Price : $8.95]

Lexicon Pharmaceuticals says that after receiving recent FDA feedback it plans to resubmit its NDA for sotagliflozin oral tablets ...

Acadia Pharmaceuticals Nixes Schizophrenia Drug

[ Price : $8.95]

Acadia Pharmaceuticals stops developing pimavanserin for treating negative symptoms of schizophrenia based on disappointing top-li...

Alzheimers Drug Development Draft Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Early Alzheimers Disease: Developing Drugs for Treatment....

Biologic Adverse Event Reporting Info Collection

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension on adverse experience reporting for licensed biologi...

Labeling for Animal Drugs Revision

[ Price : $8.95]

Federal Register proposed rule: FDA proposes to revise the requirements for the content and format of labeling for approved or con...

Windstone Medical Recalls Surgical Kits

[ Price : $8.95]

Windstone Medical Packaging recalls its Local Lower Extremity Pack, In-House Ocular Pack and Closure Kit in response to Nurse Assi...

FDA Rejects Viatris/Mapi Multiple Sclerosis Drug

[ Price : $8.95]

FDA sends Viatris/Mapi Pharma a complete response letter on the NDA for GA Depot 40 mg, a long-acting glatiramer acetate being inv...

Abbott Recalls HeartMate Touch System

[ Price : $8.95]

Abbott recalls its HeartMate Touch System (version 1.0.32) due to the risk of an unexpected pump stop or start.

$500 Million Boost to FDA in Presidents Budget Proposal

[ Price : $8.95]

President Biden seeks a $500 million boost in FDAs spending in fiscal year 2025, which is 7.4% more than the current $6.7 billion ...