FDA
The second half of March is a busy month for the U.S. Food and Drug Administration (FDA), with quite a few PDUFA dates scheduled. Here’s a look at this week’s target action dates.
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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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The Food and Drug Administration is taking care of a few approvals and committee meetings ahead of the Thanksgiving holiday week. They include drugs for COPD, a pain drug, and a sublingual film formulation of a well-known drug for erectile dysfunction. Here’s a look.
Joseph Eid, head of medical at BMS, said Empliciti in combination with pomalidomide and dexamethasone has provided proof that the medication can extend the time a patient can live without the worsening of his or her disease.
According to the American Cancer Society, almost 601,000 people in the U.S. died of cancer in 2017. The two most common types of cancer are lung cancer and breast cancer, followed by colorectal cancer, prostate cancer and stomach cancer.
Two days after the FDA approved a powerful new sublingual opioid medication, FDA Commissioner Scott Gottlieb used his Twitter account to defend the approval amid concerns that the medication is susceptible to abuse.
The U.S. FDA approved Pfizer’s Lorbrena (lorlatinib) for ALK-positive metastatic non-small cell lung cancer (NSCLC) in patients whose disease hasn’t progressed on crizotinib and at least one other ALK inhibitor or for patients whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor.
Although there is some slowdown as the FDA moves into the holiday season in late November and into December, there are still upcoming target action dates. Here’s a look at this week’s PDUFA dates.
The U.S. Food and Drug Administration (FDA) gave the green light to Hyrimoz, a biosimilar to AbbVie’s blockbuster drug Humira, five years ahead of the time it can be launched in U.S. markets.
Merck’s blockbuster anti-PD-1 therapy Keytruda has snagged another regulatory approval from the U.S. Food and Drug Administration. The checkpoint inhibitor has been approved, in combination with chemotherapy, as a first-line treatment for patients with metastatic squamous non-small cell lung cancer.
myPTM Allows Patients to Personalize Their Treatment by Delivering On-Demand Boluses, or Drug Doses, Within Therapeutic Limits Set by Their Physician
Next-Generation Thoracic Endovascular Repair (TEVAR) Device Expands Applicability to Broader Range of Patients