FDA
Aaron Kesselheim, a professor of Medicine at Harvard Medical School and has served on the advisory committee since 2015, has stepped down.
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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Myxredlin is intended for use only in acute care settings under medical supervision.
The drug is approved for use for management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, adjunctive therapy for partial-onset seizures in patients 17 years of age and older, fibromyalgia, and neuropathic pain associated with spinal cord injury.
The FDA approval marks the first for oral ulcers associated with Behçet’s Disease and the third for Otezla.
Phase 1/2 trial to be HOOKIPA’s first clinical trial in immuno-oncology
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to AstraZeneca over its supplemental New Drug Application (sNDA) for Farxiga (dapagliflozin) as an adjunct treatment to insulin for type 1 diabetes (T1D) when insulin alone doesn’t keep blood sugar levels under control.
The FDA approval marks the first drug approved for Azurity, a company formed from the merger of CutistPharma and Silvergate.
SonoCloud ultrasound device for glioblastoma patients will be tested for first time at US clinical sites
Da Volterra, a clinical-stage biopharmaceutical company developing new therapeutics to protect the intestinal microbiota, announced the completion of patient recruitment for its Phase 2 trial ‘SHIELD’ evaluating DAV132 in patients receiving antibiotics.
Shares of Karyopharm Therapeutics have skyrocketed more than 36% after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s treatment for multiple myeloma.
As fireworks illuminate the night skies across the United States this weekend in celebration of Independence Day, BioSpace takes a look at some of the highlights of the pharma industry from the first half of 2019 and earlier that provides millions of patients with the independence of health.