FDA
Semglee was approved under the FDA’s 351(k) pathway, a biologics license application process. It ensures that the bio similarity is based on animal studies, clinical trials, and analytical studies.
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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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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.
The latest approval for Calquence, a Bruton tyrosine kinase inhibitor, was granted under the FDA’s Real-Time Oncology Review and newly established Project Orbis programs.
The approval marks the first time a Korean company independently brought a drug from discovery to FDA approval.
The U.S. Food and Drug Administration approved Alnylam Pharmaceuticals’ Givlaari (givosiran) for acute hepatic porphyria.
AbbVie’s blockbuster drug Humira just got another challenger to its share of the market in the United States when its patent expires in 2023.
“The approval of Adakveo marks a new era in the treatment of sickle cell disease, a genetic condition that places an extraordinary burden of unpredictable pain crises on patients and their families,” said Susanne Schaffert, president of Novartis Oncology.