Krystal Gets First FDA Approval for Redosable Gene Therapy, Rare Skin Disease 5/22/2023

Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat 5/22/2023

Hepion Claims Phase II NASH Victory Following Intercept’s Adcomm Defeat 5/22/2023

Biopharma Targets the Untapped Potential of the Human Healthspan 5/22/2023

Opinion: Sarepta Enters Uncharted Territory with Adcomm Approval 5/22/2023

FDA Action Alert: Blueprint, Opiant and Lexicon 5/22/2023

ReCode–a New Contestant in the mRNA Race 5/22/2023

Intercept’s NASH Treatment Fails to Win Support of FDA Advisory Committee 5/20/2023

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316.

A team led by researchers at Baylor College of Medicine is coming closer to delivering on the promise of personalized breast cancer therapy with a strategy to predict the most likely response of a cancer to a specific less toxic treatment regimen.

In this study published in the journal Clinical Cancer Research, the scientists developed and validated in clinical trials a multiparameter molecular classifier test to predict with a high degree of confidence which patients with HER2-positive (HER2+) breast cancer would be candidates for anti-HER2 therapy alone without the need for chemotherapy.

AbbVie Adds Crohn’s Disease to Rinvoq’s Growing List of Indications 5/19/2023

FDA Panel Backs Pfizer’s Maternal RSV Vaccine Despite Safety Concerns 5/19/2023

FDA Approves Bausch + Lomb, Novaliq Dry Eye Disease Drug 5/19/2023

Pfizer and Thermo Fisher Scientific Inc. (NYSE: TMO) announced they have entered into a collaboration agreement to help increase local access to next-generation sequencing (NGS)-based testing for lung and breast cancer patients in more than 30 countries across Latin America, Africa, the Middle East and Asia where advanced genomic testing has previously been limited or unavailable.

Researchers at UCLA Health and Harvard have identified 10 pesticides that significantly damaged neurons implicated in the development of Parkinson’s disease, providing new clues about environmental toxins' role in the disease.

While environmental factors such as pesticide exposure have long been linked to Parkinson's, it has been harder to pinpoint which pesticides may raise risk for the neurodegenerative disorder.

Roche’s MS Drug Hits Phase II Mark, Rivals Remain Under Clinical Holds 5/17/2023

Lilly’s Prevail, Doudna’s Scribe Partner on Genetic Treatments for Neuro Diseases 5/17/2023

PTC Touts Promising Late-Stage Results in Adults, Children with PKU 5/17/2023

CVS Health Winding Down Clinical Trial Business 5/17/2023

Athenex Files for Bankruptcy, Cuts 123 Jobs Across New York 5/17/2023