Jason Jardine on Pharmaceutical Industry

FDA Approves Colony Stimulating Factor-1 Receptor (Csf-1R) Blocking Antibody for Treatment of Chronic Graft-Versus-Host Disease...

On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more

9/13/2024 / Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Regenerative Medicine , Stem cells

The First FDA Approved, Chinese Developed, PD-1 Inhibitor For Nasopharyngeal Carcinoma

On October 27th, 2023, the U.S. Food and Drug Administration (FDA) approved LOQTORZITM (toripalimab-tpzi), developed by Coherus BioSciences, Inc., and Shanghai Junshi Biosciences Co., Ltd., for two indications: 1) in...more

11/27/2023 / FDA Approval , Food and Drug Administration (FDA) , Healthcare , Life Sciences , Pharmaceutical Industry , Prescription Drugs

FDA Approves Generic Fluorescein Injection

On September 26, 2023, Nexus Pharmaceuticals, LLC announced that it had received approval from the U.S. Food and Drug Administration (FDA) for Fluorescein Injection, USP. Nexus Pharmaceuticals is a maker of generic drugs....more

9/29/2023 / FDA Approval , Food and Drug Administration (FDA) , Generic Drugs , Healthcare , Life Sciences , Pharmaceutical Industry , Pharmaceutical Patents , Prescription Drugs

FDA Statement Regarding Quality Assurance Efforts for Foreign Drug Manufacturing Facilities

On September 5, 2018, the Food and Drug Administration (FDA) published a press release highlighting recent actions taken to ensure that pharmaceuticals meet high-quality standards. Currently, there are over 5,000...more

9/21/2018 / CGMP , Food and Drug Administration (FDA) , International Harmonization , Pharmaceutical Industry , Policies and Procedures , Prescription Drugs , Public Safety , Quality Assurance Programs

Right to Try Act Gives Terminal Patients Opportunity to Try Early Therapies

Often those with terminal illnesses wish to try new experimental therapies. Now they can if they are willing to accept the risks. On May 30, 2018, President Trump signed into law the Right to Try Act. The Act allows eligible...more

6/22/2018 / Clinical Trials , Health Tourism , Manufacturer Liability , Non-Approved Drugs , Pharmaceutical Industry , Right to Try , Terminal Illness Treatments , Trump Administration

FDA Approves Zelboraf for Treatment of a Rare Cancer

On November 6th, 2017, the U.S. Food and Drug Administration (FDA) approved the drug Zelboraf (vemurafenib), for the treatment of Erdheim-Chester Disease (ECD). The FDA approved Zelboraf under Priority Review, Breakthrough...more

11/21/2017 / Cancer , Fast Track Process , FDA Approval , Food and Drug Administration (FDA) , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs

FDA Approves Final Label for Syndros™

On May 24, 2017, the Food and Drug Administration (FDA) approved the final label for Syndros™ (dronabinol) oral solution, a Schedule II (CII) controlled substance. Syndros™ was initially approved by the FDA on July 5, 2016...more

6/13/2017 / Controlled Substances , FDA Approval , Medical Marijuana , Pharmaceutical Industry , Prescription Drugs

Orphan Drug Designation

“Orphan drug” is a designation given to certain pharmaceutical and biological products (drugs) that would likely not be developed due to a relatively small patient population and limited potential for profitability. In the...more

4/1/2017 / Biologics , Clinical Trials , FDA Approval , Orphan Drugs , Pharmaceutical Industry , Product Exclusivity , Startups , Tax Credits

22 Novel Drugs Approved by FDA in 2016

Every year, the FDA’s Center for Drug Evaluation and Research (CDER) approves new medications. Some medications are variations of existing products, such as generic formulations or new dosage forms of previously-approved...more

2/1/2017 / Biologics , FDA Approval , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

Jason Jardine

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