We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The Biden administration yesterday rolled out a plan to offer booster shots to people who are fully vaccinated against SARS-CoV2 with mRNA vaccines starting on Sept. 20. Read More
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to cut an estimated 20 percent of its workforce, around 300 employees — and aims to take a back-seat approach in approving generics and to rely on actions taken by EU and U.S. drug regulators. Read More
FDA investigators observed several deficiencies in a March 30 to April 7 inspection of San Diego-based contract development and manufacturing organization (CDMO) Irisys, including the quality unit’s failure to document the review and approval of each batch production record. Read More
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