Camargo

NOVEMBER 11, 2020

Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. When the FDA requires a product’s labeling to include a boxed warning (also called a “black box warning” because the text is surrounded by black border), the potential market value of the drug often drops severely.

Development 242

Development Bioequivalency Generic Drugs Production 242

Drug Discovery World

SEPTEMBER 14, 2023

In May 2023, Pfizer announced the FDA approval Abrysvo, the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. Read about more recent corporate appointments here.

Drugs 59

Drugs Vaccination Vaccine Medicine 59

Delveinsight

DECEMBER 15, 2020

The drug, Ruxolitinib, is commercialized by Incyte in the US; and is licensed to Novartis outside the U.S. Sold under the name Jakafi, it is FDA-approved for the treatment of polycythemia vera (PV) in adults. Pfizer, BioNTech COVID-19 Vaccine rolls out in a watershed moment.

Vaccination 54

Vaccination Vaccine Gene Therapy Gene 54

XTalks

APRIL 24, 2023

The Recent Increase in Cellular and Gene Therapy Product Approvals for Rare Diseases As of December 2022, the FDA’s Office of Tissue and Advanced Therapies (OTAT) has approved 27 cellular and gene therapy products. Last year, the FDA approved five novel cellular and gene therapy products with orphan drug designation.

Gene Therapy 95

Gene Therapy Gene Trials Clinical Trials 95

Pharmaceutical Technology

FEBRUARY 26, 2023

In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. Although research here is about 20 years old, it remains new compared to other areas like genomics, says Gilbert.

Bacteria 278

Bacteria Trials Research Medicine 278

pharmaphorum

FEBRUARY 11, 2022

The subject from the initial study of RGX-111 that led to FDA approval of the phase 1/2 trial also showed better-tan-expected improvements on those skills over a follow-up period of around 20 months. The post Regenxbio expands MPS I gene therapy trial after first look at data appeared first on.

Gene Therapy 111

Gene Therapy Gene Trials FDA Approval 111

The Pharma Data

AUGUST 6, 2020

FDA) approval of Opdivo (nivolumab) for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. This approval was based on the Phase 3 CheckMate -9LA study. Oncology and Hematology. Regulatory.

Production 52

Production Branding Marketing Licensing 52