FDA
The U.S. FDA has approved Regeneron and Sanofi’s PD-1 inhibitor Libtayo® for the treatment of patients with advanced basal cell carcinoma with a history of treatment with a hedgehog pathway inhibitor or in patients with advanced BCC who are considered ineligible for an HHI.
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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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Amry today announces that the US Food and Drug Administration (“FDA”) has granted Investigational New Drug (“IND”) clearance for AP101.
Loxo Oncology, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-292
Fibrocell Science, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to FCX-013, the Company’s clinical stage candidate for the treatment of moderate to severe localized scleroderma
Privately-held ITF Pharma snagged regulatory approval for Tiglutik, a liquid formulation of riluzole for the treatment of amyotrophic lateral sclerosis.
The U.S. Food and Drug Administration has had a busy August. In addition to the number of draft guidance documents the agency issued during the month, the FDA has also been busy approving a number of new treatments for a variety of diseases.
Nearly two months ahead of the planned PDUFA date, the U.S. Food and Drug Administration approved two new HIV-1 treatments developed by Merck. The FDA gave the go ahead for Delstrigo, a once-per day triple combination treatment and Pifeltro, a new non-nucleoside reverse transcriptase inhibitor.
Hemophilia A patients have another treatment option. This morning the U.S. Food and Drug Administration gave the nod to Bayer AG’s new treatment, Jivi (BAY94-9027).
Recently, Milton Packer, a renowned cardiologist at Baylor Scott & White Health, wrote a criticism of the Orphan Drug Act and the resulting problems caused by the biopharma industry. John LaMattina, formerly president of Pfizer Global Research and Development and a current senior partner at PureTech Ventures, responded to the editorial in Forbes. Let’s take a look.
The U.S. Food and Drug Administration (FDA) approved Shire’s Takhzyro (lanadelumab-flyo) injection to prevent attacks of hereditary angioedema (HAE) in people 12 years of age and older. The drug was accepted while under priority review.
Shares of AbbVie are inching up this morning after the company announced it had secured regulatory approval for Imbruvica as a treatment for patients with a rare blood disease.