Ryan Chandanais, MS, CPhT

Advances in biotechnology have improved the production and recombination of antibodies, leading to improvements in monoclonal antibody therapies.

The placement of clinical pharmacists at the nexus of functional pharmacogenomics and in specialty pharmacy care makes good sense.

Basket studies can be useful to determine if a drug targeting a certain genetic mutation at a particular site may be effective in treating that same genetic mutation found in cancer located in another site of the body.

The FDA has programs designed to expedite the drug development and review processes for promising pipeline products. The newest of these programs is Regenerative Medicine Advanced Therapy (RMAT).

Migraine is a condition characterized mainly by severe and recurrent headaches. Approximately 12% of the general population experiences migraines, with a higher frequency in women than men.

The FDA issues a CRL when it decides that an application does not meet all the requirements for approval.

Speeding up the review of drugs to treat serious diseases makes sense. Here is a look at how it works.

It takes a great deal of time and resources for a manufacturer to complete all the necessary requirements to submit a successful NDA to the FDA for review.

The most impactful of the FDA designations, this status may be applied to drugs used to treat serious or life-threatening conditions.

Priority review voucher program is designed to focus attention on otherwise neglected diseases.