BioSpace

DECEMBER 12, 2023

The deal follows the FDA approval of Vertex’s gene-editing sickle cell treatment and Editas’ earlier legal battle over rights to the technology.

Gene Editing 59

Gene Editing Licensing Licensing FDA Approval 59

Pharmaceutical Technology

JANUARY 19, 2023

However, it is possible to target CD33 in the clinic, as evidenced by the FDA approval of Pfizer’s anti-CD33 antibody-drug conjugate Mylotarg (gemtuzumab ozogamicin) in 2000. NiCord’s biologics license application is currently being investigated by the FDA with a review date set by May 2023.

Marketing 130

Marketing Gene Editing Production Sales 130

XTalks

DECEMBER 29, 2022

As of December 16, 2022, there are seven US Food and Drug Administration (FDA) approved gene therapies. In 2022 alone, the US regulator approved four new gene therapies, showing the high interest in getting these therapies to market. In 2023, a number of gene therapies are expected to get the FDA green light.

Life Science 52

Life Science Gene Therapy Gene Manufacturing 52

XTalks

JANUARY 4, 2024

There is a significant focus on developing gene therapies as longer-term solutions for the disease. Pfizer licensed Beqvez from Spark Therapeutics nine years ago. Beqvez is set to rival CSL Behring’s Hemgenix (etranacogene dezaparvovecfor), which was the first gene therapy approved for hemophilia B. Priced at $3.5

Gene Therapy 111

Gene Therapy Gene Gene Editing Sales 111

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

Drug Discovery World

FEBRUARY 22, 2024

The FDA has approved the supplemental Biologics License Application (sBLA) supporting the traditional approval of LEQEMBI (lecanemab-irmb) injection, for reducing the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD).

Drugs 59

Drugs Gene Clinical Trials Clinical Trials 59