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AstraZeneca Scraps Monalizumab Clinical Study 08/01/2022

FTC Endorsement Guides Require Attention: Lawyer 07/29/2022

Opioid Questions Continue to Dog Califf: AP 07/28/2022

Share All Cancer Drug Approval Data: Study 07/28/2022

3 Lessons Learned from Fosamax ‘Failure-to-Warn’ Case 07/28/2022

Micro-Organospheres Show Cancer Proof of Concept: NCI 07/28/2022

Covidien Recalls Palindrome and Mahurkar Catheters 07/28/2022

Cassava Sciences Under Criminal Investigation: Reuters 07/27/2022

FDA OKs Bavarian Nordic’s Vaccine Facility 07/27/2022

Non-Curative Setting Available Therapy 07/27/2022

Viz.ai Subdural Hemorrhage Detector Cleared 07/27/2022

Lexicon Re-files NDA for Heart Failure Drug 07/27/2022

Cannabis Administration and Opportunity Act 07/27/2022

‘Objectionable Conditions’ in Goodman Eye Center Trial 07/27/2022

CGMP Violations in Bi-Coastal Pharma Inspection 07/26/2022

API Deviations Found at Jost Chemical 07/26/2022

Avadel Sues FDA Over Lumryz NDA Delay 07/26/2022

Develop Regulatory Framework for Synthetic Cells: Paper 07/26/2022

FDA Accepts Biogen Tofersen NDA for Rare ALS 07/26/2022

FDA Grants Taiho Oncology Lonsurf Petition 07/26/2022

Many Supplements Stay on Market After FDA Warning 07/26/2022

Biotronik Pays $13 Million Under False Claims Case 07/25/2022

Zipperer Debarred by FDA for 5 Years 07/25/2022

Draft Guide on Real-time Oncology Reviews 07/25/2022

Compliance Extension Date on Unique Device IDs 07/22/2022

FDA Proposes to Move to 12-digit National Drug Codes 07/22/2022

Regulatory Review Didn’t Slow Covid Vaccines: Marks 07/21/2022

BioCircuit Technologies 510(k) for Nerve Tape 07/21/2022

Orange Book Therapeutic Equivalence Guide 07/21/2022

New Renuvion/J-Plasma Handpiece Available: FDA 07/21/2022

Whitmer Wants Mifepristone REMS Lifted 07/21/2022

FDA Refusing to Approve ITCA 650 09/02/2021

Uproar Greets FDA’s Aduhelm OK for Alzheimer’s 06/08/2021

CGMP Problems at Catalent Pharma Solutions 04/08/2008

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