Early this week, Pfizer and the Scripps Research Institute announced that they would be suing Israel’s Dexcel Pharma for patent infringement affecting Vyndamax, a drug that already generated $818...
On August 7, 2023, the American National Red Cross announced that it would adopt the United States Food and Drug Administration’s new blood donation protocols. This shift will widen donor...
Today, Aspen Neuroscience announced that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a new Parkinson’s Disease gene...
Last week, the United States Food and Drug Administration approved the first oral treatment for postpartum depression (PPD). Zuranolone was approved on August 4, 2023, just days after a study in the...
On July 28, 2023, Lupin Pharmaceuticals, a manufacturer based out of Baltimore, MD, voluntarily recalled two lots of Tydemy. The drug is an estrogen and progestin oral contraceptive, also known as a...
On August 1, 2023, the United States Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) released a public statement updating Americans on the ongoing shortages of prescription...
On July 28, 2023, the United States Food and Drug Administration (FDA) approved ReVive, an opioid reversal medication manufactured by Harm Reduction Therapeutics, a nonprofit pharmaceutical company. The concept of a nonprofit...
Four months after approving the first over-the-counter (OTC) naloxone, the FDA has made another harm reduction tool available by supporting a second OTC Naloxone nasal spray, RiVive. The nasal spray...
On July 27, 2023, the United States Food and Drug Administration (FDA) issued a draft guidance titled Clinical Considerations for Studies of Device Intended to Treat Opioid Use Disorder (OUD) as part...
On July 17, 2023, the FDA added to the arsenal of respiratory syncytial virus (RSV) prevention tools by approving Beyfortus, a monoclonal antibody for preventing the infection in children two years old...
After months of deliberation, the United States Food and Drug Administration (FDA) approved the first hormonal oral contraceptive for non-prescription over-the-counter (OTC) sale. This historical...
On July 6, 2023, Cipla US recalled six batches of its albuterol sulfate inhalation aerosol, 90 mcg (200 MI). According to the release published by the FDA on July 7, 2023, the company cited a container...
The Centers for Disease Control and Prevention (CDC) advised older and immunocompromised adults in the United States to get the newly available respiratory syncytial virus (RSV) vaccine. The CDC...
On Thursday, the FDA announced that it would grant GSK a fast track designation for its gonorrhea vaccine. The fast track process expedites the review process for drugs used to treat serious conditions...
In a recent conversation at the 2023 World Medical Innovation Forum (WMIF), sponsored by Mass General Brigham Hospital and Bank of America (BoA), in Boston on June 13, 2023, prominent figures in the healthcare industry, Lindsey Baden, MD,...
On June 23, 2023, the United States Food and Drug Administration issued its first draft guidance on using psychedelic drugs in clinical trials. Marking a pivot in the clinical trial landscape, these...
Last week, on June 20, 2023, the United States Food and Drug Administration (FDA) launched a pilot program to reduce the risk of laboratory-developed tests to identify cancer biomarkers. The program...
The healthcare industry relies heavily on pharmaceutical compounding, as it allows for personalized medication solutions to meet the specific requirements of individual patients. By delving into the vital components of pharmaceutical...
On June 21, 2023, Bluebird Bio issued a press release announcing that the FDA had granted its biological license application (BLA) for a new sickle cell disease (SCD) treatment priority review...
Adding to the arsenal of tools providers have to manage type 2 diabetes (T2D), the FDA has approved a new pediatric medication for managing the condition. The approval of Jardiance and Synjardy to...
