FDA
A more detailed review of data by the FDA showed that GLP-1 drugs do not increase the risk of suicidal ideation or behavior.
FEATURED STORIES
After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
Subscribe to ClinicaSpace
Clinical trial results, research news, the latest in cancer and cell and gene therapy, in your inbox every Monday
THE LATEST
The U.S. Food and Drug Administration is wrapping up 2019 with a few PDUFA dates. Here’s a look.
The agency is requiring Sarepta to conduct a confirmatory trial, which Sarepta says will conclude by 2024.
The company calls the system the first and only “ingestible event marker to transmit digital messages” from inside the body to a receiver without need for direct skin contact.
Over the course of the past year, Novartis has seen significant success with the approval of five drugs that have blockbuster potential and the company sees an additional 25 potential blockbuster drugs in its pipeline.
The U.S. Food and Drug Administration approved Genentech’s Tecentriq plus chemotherapy as a first-line treatment of metastatic non-squamous non-small cell lung cancer.
Previously, Toujeo was approved only for adults aged 18 years and older.
SK Life Science, Inc. Receives US FDA Approval for cenobamate tablets for the Treatment of Partial-Onset Seizures in Adults with Epilepsy
First and only FDA-approved sickle hemoglobin polymerization inhibitor, a new class of therapy
Ted W. Love, president and chief executive officer of GBT, called the approval of Oxbryta a major milestone for the company and for patients with sickle cell disease.
Shares of specialty pharmacy company Aquestive Therapeutics are up more than 18% in premarket trading following a late Friday afternoon approval from the U.S. FDA for Exservan, a treatment for amyotrophic lateral sclerosis.