FDA
Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. FDA, which will speed up the regulatory process for these medications.
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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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Although January was a fairly slow month for PDUFA dates for the U.S. Food and Drug Administration, February has a stronger schedule.
The approval was based on two randomized open-label clinical trials that evaluated the combination of empagliflozin, linagliptin and metformin and their individual components in healthy adults.
Dificid is a macrolide antibiotic that was previously approved for CDAD in adults.
Robert Bazemore, president and chief executive officer of Epizyme, called the accelerated approval of Tezverik “a landmark event” for people with epithelioid sarcoma, a soft-tissue cancer.
Tuesday afternoon the U.S. Food and Drug Administration approved Tepezza (teprotumumab-trbw) as the first treatment for this condition.
AstraZeneca’s Imfinzi (durvalumab) and tremelimumab were granted Orphan Drug designation by the U.S. Food and Drug Administration as a possible treatment for hepatocellular carcinoma.
For patients with diabetes, the new indication could become a key for survival as there is a well-established link between cardiovascular disease and type 2 diabetes.
Investigators found that the U.S. Food and Drug Administration is approving drugs faster than ever. Unfortunately, it appears that the agency is also approving those drugs on less data and weaker evidence.
What’s New at the J.P. Morgan Life Healthcare Conference?
Emma Walmsley, chief executive officer of GlaxoSmithKline, is predicting a good year for her company, with the potential of six regulatory approvals in the United States.