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The FDA’s Office of Prescription Drug Promotion (OPDP) has issued its third untitled letter of the year to Deer Park, Ill.-based Eton Pharmaceuticals over advertisements for the company’s Alkindi Sprinkle (hydrocortisone) oral granule, a treatment for the pediatric hormone disorder adrenocortical insufficiency. Read More
Pfizer and BioNTech have submitted data to the FDA for approval of a third — or booster — dose of the their COVID-19 vaccine in healthy adults. Read More
FDA veteran Janet Woodcock is still in the role of Acting FDA Commissioner almost eight months after President Biden took office, and there’s no news out of the White House about any nominees for the position. Read More
The agency acknowledges that “there may be some confusion about the applicability of certain statutory and regulatory provisions” to Pre-Hatch-Waxman ANDAs. Read More
Mylan Pharmaceuticals has petitioned the U.S. Supreme Court to overturn a controversial U.S. Patent and Trademark Office (USPTO) rule that allows the USPTO’s Patent Trial and Appeal Board (PTAB) to deny a patent review petition because of the progress of a parallel U.S. district court proceeding on the same patent. Read More
The FDA has lifted its clinical hold on Rocket Pharmaceuticals’ investigational gene therapy for Danon disease, an ultra-rare genetic disorder that can lead to heart failure in children and young adults. Read More
Merck is the latest big drugmaker to announce that it will stop sales of 340B-discounted products to contract pharmacies, ignoring warnings from HHS that such moves made by other drugmakers are in violation of federal law. Read More
Other insurers, including UnitedHealth, say they are waiting for a review of coverage by the Centers for Medicare and Medicaid Services before reaching their decision. Read More
The FDA is asking for public comments on how it regulates generic drugs that were approved prior to the Hatch-Waxman Amendments of 1984, which established the current abbreviated new drug application (ANDA) process for generics. Read More
Less than two weeks after abruptly withdrawing a notice announcing a double-digit increase in user fees for drugmakers under the Prescription Drug User Fee Act (PDUFA), the FDA has issued the notice with reductions in the proposed fees. Read More
An advisory panel assembled by the Centers for Disease Control and Prevention (CDC) voted unanimously on Friday to endorse the FDA’s expanded Emergency Use Authorizations allowing a third dose of the Pfizer/BioNTech and Moderna COVID-19 vaccines for certain immunocompromised individuals. Read More