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Xortx to Pursue Accelerated Approval for Xorlo 05/04/2023

Device Regulatory Science Tool Catalog Update 05/04/2023

Califf Recommends FDA Reforms for Pandemic Bill 05/04/2023

FDA Novo Nordisk Concizumab Complete Response Letter 05/04/2023

Members of Congress Seek Mifepristone Reversal 05/03/2023

Rentschler Biopharma Germany Site 483 05/03/2023

Lilly Eyes Fast OK for Donanemab in Alzheimer’s 05/03/2023

GSK Wins Approval for 1st RSV Vaccine 05/03/2023

ICH Quality Risk Management Guidance Published 05/03/2023

Innovative Manufacturing Approaches Notice Corrected 05/03/2023

PDUFA User Fee Assessment Guidance 05/03/2023

Reps. Question FDA Pace for New Covid Therapeutics 05/03/2023

Trade Groups Comment on Externally Controlled Trials 05/03/2023

Smart Heart Toilet Seat Cleared by FDA 05/03/2023

Accelerated Approval Withdrawals Likely to Increase: Attorneys 05/02/2023

CGMP Violations in Voyant Beauty Inspection 05/02/2023

Decentralized Clinical Trial Recommendations 05/02/2023

DirectSync Gets ‘Breakthrough’ on Spinal Fusion Device 05/02/2023

Vanda Says FDA Disclosed Trade Secrets to Competitors 05/02/2023

FDA Finishes Posting OTC Drug Deemed Final Orders 05/02/2023

FDA Partial Hold on Sun JAK Inhibitor Trial 05/02/2023

Medtronic Next-Gen Micra Pacemakers Approved 05/01/2023

Astellas/Pfizer Mulling sNDA for Xtandi 05/01/2023

Bipartisan Bill on Preventing Drug Shortages 05/01/2023

Complete Response on Hypoparathyroidism NDA 05/01/2023

Princeton BioMeditech OTC Covid Test Authorized 05/01/2023

Lilly Issued 483 on Aseptic Operations 05/01/2023

Guide on Smoking Cessation Products 04/28/2023

Comments on Data/Tech Strategic Plan 04/28/2023

DTC Research to Examine Treatment Tradeoffs 04/28/2023

Petition Seeks Removal of Bamboo’s NarxCare Software 04/28/2023

Gene Therapy Guide on NonClinical Biodistribution 04/28/2023

Teva Recalls Fentanyl Lots Over Product Insert 04/28/2023

FDA Approves Otsuka/Lundbeck Schizophrenia Drug 04/28/2023

ViiV Dovato Ad Claims Challenged 04/27/2023

Drug Supply Chain Independence Bill 04/27/2023

Ultromics Gets Breakthrough Status for AI Device 04/27/2023

FDA Approves Oral Fecal Microbiota Capsules 04/27/2023

Prevent Makena Compounding: Public Citizen 04/27/2023

Gillibrand Bill to Speed FDA Approval of Some Drugs 04/27/2023

Quality Management Maturity Dividing Industry: PDA 04/27/2023

FDA Planning TV Ad Endorser Research 04/27/2023

Lilly Planning Tirzepatide Submission Soon 04/27/2023

CVM Electronic Submission Registration 04/26/2023

DefenCath NDA to be Resubmitted by Mid-May 04/26/2023

Nonrandom Data Can Emulate Random Trials: Study 04/26/2023

Iptacopan FDA Submission Coming Soon: Novartis 04/26/2023

Alvotech FDA-483 Released 04/26/2023

Bankrupt Akorn Recalls All Products 04/26/2023

Vertex Gains Expanded Use for Cystic Fibrosis Drug 04/26/2023

Advisors Asked About Olaparib sNDA Population 04/26/2023

FDA Lifts Warning Letter Against Medtronic 04/26/2023

QS, MDR, Other Violations in Medivance Inspection 04/25/2023

Medolife Illegally Selling Unapproved New Drugs: FDA 04/25/2023

Streamlined Cancer Trials Can Cause ‘Discomfort’: Singh 04/25/2023

Biogen Accelerated Approval for ALS Drug 04/25/2023

Senate Bipartisan Agreement on FDA Reform Bills 04/25/2023

FDA Sends ‘Non-Compliance’ Letter to Sun Pharma 04/25/2023

CGMP Violations at Egypt’s Pharmaplast 04/25/2023

Florida Files 2nd Drug Import Suit Against FDA 04/25/2023

Medtronic’s MiniMed 780G Gets FDA Approval 04/24/2023

Generic Group Questions Guide on Guidance Meetings 04/24/2023

Foghorn Therapeutics Hit with Partial Clinical Hold 04/24/2023

Supreme Court Gives FDA Temporary Victory 04/24/2023

OPDP Plans Survey on DTC Quantitative Claims 04/24/2023

Avanos Medical Recalls Respiratory Suction Device 04/21/2023

FDA Extends Review of Daiichi Leukemia NDA 04/21/2023

CDER Denies Bausch Petition on Duobrii ANDAs 04/21/2023

Novartis Gets Another Facility OK’d for Pluvicto 04/21/2023

DTC Research Raises Concern on Endpoints in Cancer Ads 04/21/2023

10 Observations in Lupin FDA-483 04/20/2023

Sarepta Comments on Golodirsen PSG 04/20/2023

GE Healthcare’s Carescape Patient Monitor Cleared 04/20/2023

FDA Describes New QSAR Model 04/20/2023

FDA Failed to Collect $45 bil. Drug Trial Fines: Students 04/20/2023

Califf Testifies on Accelerated Approvals 04/20/2023

BelGene Gastric Cancer Drug Trial Hits Primary Endpoint 04/20/2023

CGMP Violations at Zermat International 04/19/2023

Fresenius Kabi Recalls Ivenix Infusion Device 04/19/2023

North American Diagnostics Illegal Covid Tests 04/19/2023

Radiation Syndrome Drug Development Guidance 04/19/2023

NCI Sees Revumenib Promise for Some Leukemias 04/19/2023

FDA Cautions Compounders on Bulk Sources 04/19/2023

FDA Drug Inspections Slow to Recover: Analysis 04/19/2023

Guidance Shows Importance of Sponsor Oversight: Attorneys 04/19/2023

Generic Mifepristone Maker Sues FDA 04/19/2023

High Court Adds 2 Days to Mifepristone Stay 04/19/2023

EMA/FDA Bioequivalence Info Sharing Pact Adds Ireland 04/19/2023

FDA OKs 2nd Covid Booster for Some People 04/18/2023

Lessons Learned from Rare Disease Trials During Covid 04/18/2023

OND Expands Regulatory Science Research 04/18/2023

Intarcia Raises NDA Advisory Committee Issues 04/18/2023

House Oversight Panel Puts Heat on FDA Over CBD 04/18/2023

Research Describes Drug Ad Data Display 04/18/2023

Royal Chemical Inspection Finds CGMP Violations 04/18/2023

Multiple Abbott i-STAT Test Violations 04/18/2023

GSK Plans NDA for Antibiotic Gepotidacin 04/17/2023

FDA ‘Top Cop’ McMeekin Retiring 6/30, Then Many More 04/17/2023

Gamida Cell Therapy Approved by FDA 04/17/2023

Workshop on Rare Disease Endoints 04/17/2023

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