In RFK Jr., drugmakers face an antagonist with regulatory power
Anxious and bewildered, some drugmakers are reaching out to their lobbyists about how Robert Kennedy’s pending nomination ...
The FDA wants these cold medicines off the shelves. Should Canada follow?
The FDA has proposed removing phenylephrine, a common ingredient in decongestants, due to its ineffectiveness, which may ...
Syndax confirms FDA approval of Revuforj for acute leukemia
Pharmaceuticals announced that the U.S. FDA has approved Revuforj as the first and only menin inhibitor for the treatment of ...
Monthly Prescribing Reference7h
FDA to Review Resubmitted Dupilumab sBLA for Chronic Spontaneous Urticaria
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
CCHR Int6h
CCHR Urges FDA Overhaul to End Psychiatric Drug and Device Harms
The Mental Health Watchdog calls for reforms to protect public safety, citing decades of antidepressant, electroshock, and psychedelic drug risks.
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...
News Medical2d
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
FDA seeks to remove ingredient from cold medicines after data shows it does not work
The U.S. Food and Drug Administration is taking the first step to remove an ingredient in non-prescription cold medicines ...
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
In Robert F. Kennedy, drugmakers face antagonist with regulatory power
Pharmaceutical industry representatives in Washington are scrambling to measure the damage Robert F. Kennedy Jr. might inflict on the FDA.
GlobalData on MSN12h
FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
GlobalData on MSN4d
FDA delays priority review of Neurotech’s eye cell therapy implant
The US regulatory agency has pushed the PDUFA date by three months to 18 March 2025 to “allow for more time to review ...