In healthcare technology, the intersection of science and regulations is where innovation meets responsibility. Nowhere is this more evident than in the pharmaceutical industry, where drug safety is paramount. Regulatory compliance plays a...
With the onset of the fall season, many Americans are grappling with numerous questions about COVID-19 booster shots, the flu vaccine, and respiratory syncytial virus (RSV) protection. This year's vaccine rollout has encountered...
Yesterday, on October 3, 2023, the United States Food and Drug Administration (FDA) announced an emergency use authorization (EUA) for an updated Novavax COVID-19 vaccine to protect against the...
On August 24, 2023, the United States Food and Drug Administration approved Tyruko, natalizumab-sztn, a biosimilar for Tysabri (natalizumab), an injectable biologic for managing multiple sclerosis. The...
On August 21, 2023, the United States Food and Drug Administration (FDA) approved Abrysvo, a respiratory syncytial virus (RSV) vaccine. The drug aims to prevent illness in infants under six months by...
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...
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...
A study published in the American Journal of Psychiatry on July 26, 2023, proved that zuranolone could effectively and safely treat postpartum depression. The study supports the priority review granted...
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...
Monoclonal antibodies (mAbs), a groundbreaking class of therapeutic agents, have emerged as a transformative tool in modern medicine. With their remarkable precision and versatility, these engineered antibodies offer promising solutions...
On July 6, 2023, the FDA granted Biogen Inc and Eisai Co’s Lequembi traditional FDA approval. The approval was based on a supplemental Biologics License Application (sBLA) and prior accelerated...
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 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...
Compounded forms of semaglutide have been linked to adverse events, leading to FDA-issued warnings. As a result, the FDA recommends that patients avoid compounded semaglutide whenever the approved...
On May 22, 2023, the FDA approved Opvee, a nalmefene hydrochloride nasal spray that can reverse an opioid overdose in patients 12 and older. This approval adds a harm-reduction tool to existing tools,...
On May 18, 2023, the United States Food and Drug Administration (FDA) approved RINVOQ, manufactured by Abbvie, as a once-daily treatment for adults with moderate or severely active Crohn’s...
On May 16, 2023, the Foundation for the National Institutes of Health (FNIH) announced eight rare diseases to be explored by the Accelerating Medicines Partnership Bespoke Gene Therapy Consortium (AMP BGTC). As one of the newest additions...
