Cell and Gene Therapy Regulatory

Navigating Regulatory Complexity for Cell and Gene Therapies

Natasha Rivas

mRNA–LNP Manufacturing

The Innovators Bringing Continuous Manufacturing to Lipid Nanoparticles

Antonio Costa, Ph.D.; William Pasek

DIANT Pharma

Nitrosamine Impurities

Addressing the Evolving Nitrosamine Contamination Issue

Olon

Continuous Processing

US Food and Drug Administration (FDA) Purchase the LiFT System from DIANT® Pharma INC.

DIANT Pharma

Cultivated Meat

Leveraging Biopharma Sensor Technologies for Cultivated Meat Processes

Giovanni Campolongo

Hamilton

Cosmeceuticals

Cosmeceuticals Are Here. When Will Regulations Catch Up?

Ameena Pathan

That's Nice LLC

Column: Regulatory Spotlight

The Price of Pain: Acknowledging a Crisis and Encouraging an Alternative

David Alvaro, Ph.D.

Pharma's Almanac

Alzheimer's Diagnostic Test

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer's Disease

U.S. Food and Drug Administration

COVID-19 Breathalyzer Diagnostic

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Diagnostic Test Using Breath Samples

U.S. Food and Drug Administration

Column: Regulatory Spotlight

New FDA Guidance on Real World Evidence/Real World Data

David Alvaro, Ph.D.

Pharma's Almanac

Regulatory

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

U.S. Food and Drug Administration

Drug Update

AbbVie Provides Update Regarding RINVOQ® (upadacitinib) for the Treatment of Moderate to Severe Atopic Dermatitis in the U.S.

AbbVie

FDA Approval

FDA Grants Accelerated Approval for Aduhelm™ as the First and Only Alzheimer’s Disease Treatment to Address a Defining Pathology of the Disease

Biogen

FDA Approval

U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis

Bristol-Myers Squibb

FDA Approval

Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis

Novartis

AI

Cosmo Announces Fda Approval of Gi Genius™ Intelligent Endoscopy Module, Its Revolutionary Artificial Intelligence Device for Lesion Detection During Colonoscopy

Cosmo Pharmaceuticals

COVID-19 Diagnostic

FDA Authorizes First Single-Use, PCR Quality Over the Counter (OTC) LUCIRA CHECK IT™ COVID-19 At-Home Test. Available Now.

Lucira Health, Inc.

FDA Approval

FDA Approves Trodelvy®, the First Treatment for Metastatic Triple-Negative Breast Cancer Shown to Improve Progression-Free Survival and Overall Survival

Gilead Sciences, Inc.

FDA Approval

United Therapeutics Announces FDA Approval and Launch of Tyvaso for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease

United Therapeutics: Enabling Inspiration

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

FDA