Jason Jardine

Knobbe Martens

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Latest Posts › Clinical Trials

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FDA Panel Votes Against MDMA-Assisted Talk Therapy

On June 4, 2024, a panel of experts advising the Food and Drug Administration (FDA) on the use of the psychedelic midomafetamine (MDMA) for post-traumatic stress disorder (PTSD) voted 9-2 that MDMA in combination with talk...more

6/17/2024 / Abbreviated New Drug Application (ANDA) , Clinical Trials , Food and Drug Administration (FDA) , PTSD

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

Janssen’s Erleada Will be the First Participant in FDA’s Clinical Data Summary Pilot Program

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved Janssen Therapeutics’ Erleada (apalutamide), a non-steroidal antiandrogen for the treatment of castration-resistant non-metastatic prostate cancer....more

3/7/2018 / Cancer , Clinical Trials , FDA Approval , Federal Pilot Programs , Food and Drug Administration (FDA) , 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

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