FDA
Despite controversy over the drug’s effectiveness, it appears to have spiked interest in investing in Alzheimer’s drug companies, something that had been on the decline for several years.
FEATURED STORIES
A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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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.”
July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.
Allergan announced that the U.S. Food and Drug Administration has approved its wrinkle treatment Botox for children with upper limb spasticity. The news comes just days after rumors that the company may break up.