drug approval

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FDA’s Expedited Programs Explained

In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...

Four Benefits of Requesting an FDA Pre-IND Meeting

Although not required, a Pre-IND Meeting is a critical milestone, one that is highly recommended by the FDA. The goal of the meeting is to receive general agreement from FDA that your drug...

First Clinical Study Report Data Published for FDA Pilot Project

On Monday, March 19th, the FDA officially began a new Clinical Data Summary Pilot Program. This program is intended to “assess the feasibility of using a different format to provide required...

FDA Grants Breakthrough Therapy Status for Autism Drug

On Monday, January 29, 2018, Roche announced that FDA granted Breakthrough Therapy Designation for balovaptan, the company’s investigational oral medicine for the treatment of autism spectrum...

FDA Meetings: How to Prepare for FDA Type B Meetings

The Food and Drug Administration has laid out a drug development continuum that includes three milestones, or Type B meetings. Earliest is the Pre-IND Meeting, the second is the End of Phase 2 (EOP2)...

FDA Approves 1st Drug for Sickle Cell Disease in Nearly 20 Years

On Friday, July 7th, the FDA approved Endari (L-glutamine oral powder) to reduce the complications associated with sickle cell disease in patients age five years and older. What is Sickle Cell...

US Opioid Epidemic: NDA for Drug to Treat Opioid Use Disorder Submitted to FDA

On Tuesday, May 30th, Indivior Plc., a British company focused on addiction treatment, submitted a New Drug Application (NDA) to the FDA for its investigational drug intended to treat...

FDA Approves 1st Drug to Treat Cancer Based on Genetics of Tumor, Not Location

On Tuesday, May 23rd, the FDA granted accelerated approval to Merck & Co.’s Keytruda® (pembrolizumab), a product to treat cancers with a specific genetic feature (also known as a biomarker)....

FDA Approves New Drug to Treat ALS

Anyone who was on social media in the summer of 2014 knows what the Ice Bucket Challenge was. Videos of people completing the challenge littered most people’s social media feeds, all in hopes of...

FDA Approves New Drug for Advanced Bladder Cancer

On Monday, May 1st, the FDA approved Imfinzi™ (durvalumab). Imfinzi is manufactured by AstraZeneca, and it is a PD-L1 inhibitor indicated for the treatment of patients with locally advanced or...

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