FDA
The FDA greenlit 26 novel therapies in the first half of 2026, including four for cancer and six for orphan indications. Meanwhile, AstraZeneca and Johnson and Johnson took home a combined 11 of the agency’s 79 total approvals, including supplemental nods.
FEATURED STORIES
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech 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
Shares of Karyopharm Therapeutics have skyrocketed more than 36% after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s treatment for multiple myeloma.
As fireworks illuminate the night skies across the United States this weekend in celebration of Independence Day, BioSpace takes a look at some of the highlights of the pharma industry from the first half of 2019 and earlier that provides millions of patients with the independence of health.
Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.
The month of July is a slow one for the U.S. Food and Drug Administration (FDA), at least in terms of scheduled approval dates. Here’s a look at the three PDUFA dates the agency has on its calendar for the month.
Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.
Exiting the last week of June and heading into July, a number of companies announced results from ongoing clinical trials. Here’s a look.
Darzalex in combination with lenalidomide and dexamethasone was approved as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant.
The U.S. Food and Drug Administration (FDA) gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults that express a specific biomarker.
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
The Complete Response Letter indicated the company will need to run an “adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.”