XTalks

JUNE 17, 2022

Eli Lilly’s Olumiant (baricitinib) has won US Food and Drug Administration (FDA) approval as the first systemic treatment for severe alopecia areata (AA), an autoimmune disorder that leads to patchy baldness. The Olumiant approval is therefore a big win as it helps fulfill a significant unmet need in the area.

FDA Approval 97

FDA Approval Gene Expression Cosmetics Trials 97

The Pharma Data

NOVEMBER 21, 2021

People with achondroplasia have a genetic mutation that causes a certain growth regulation gene called fibroblast growth factor receptor 3 to be overly active, which prevents normal bone growth. 3] Achondroplasia is caused by mutations in the FGFR3 gene. The average height of an adult with achondroplasia is approximately four feet.

FDA Approval 52

FDA Approval Drugs Regulation Genetics 52

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

Development 161

Development Production Immune Response Licensing 161

The Pharma Data

NOVEMBER 12, 2021

Treatment is First FDA-Approved Option Patients Can Take Regardless of Previous Therapies. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells. Today, the U.S. Source link: [link].

FDA Approval 40

FDA Approval Gene Production Cosmetics 40

XTalks

AUGUST 2, 2023

Paxlovid was first authorized under the FDA Emergency Use Authorization in December 2021 ; however, it has received FDA approval on May 25, 2023. pneumoniae serotypes) replaced the company’s first pneumococcal conjugate vaccine Prevnar (PCV7, approved by the FDA in February 2000) in a February 2010 FDA approval.

Sales 98

Sales Manufacturing FDA Approval Life Science 98

The Pharma Data

AUGUST 1, 2021

Global Botox Cosmetic net revenues were $584 million, an increase of over 100.0 to $6.14; Raises 2021 Adjusted Diluted EPS Guidance Range from $12.37 Global Ubrelvy net revenues were $126 million. Global net revenues from the aesthetics portfolio were $1.434 billion, an increase of over 100.0

Botox 52

Botox Cosmetics Trials Clinical Trials 52