According to a recent press release, Janssen recently submitted a Biologics License Application (BLA) to the FDA for talquetamab to treat relapsed or refractory multiple myeloma. The CDC states that...
The United States Food and Drug Administration (FDA) approval process is complex and involves multiple people's input, opinions, and expertise, including the FDA advisory committees. Every time a new drug is approved, a recall is...
Last week, the FDA’s Center for Biologics Evaluation and Research announced the approval of Hemgenix, an adeno-associated virus vector-based gene therapy for adults with hemophilia B (congenital...
Clarity Pharmaceuticals recently announced its Investigational New Drug (IND) approval from the FDA to test theranostic SAR-Bombesin for prostate cancer. Prostate cancer is the fifth leading cause of...
The American Cancer Society states that ovarian cancer is the fifth leading cause of cancer-related death in women in the United States. The organization also says that, in 2022, nearly 13,000 people...
According to the CDC, of all people with diabetes, up to 10% have type 1 diabetes (T1D), sometimes referred to as juvenile or insulin-dependent diabetes. This type of diabetes typically develops early...
In a recent announcement, the Simcere Pharmaceutical Group — a global pharmaceutical company with origins in China — revealed that the FDA approved its investigational new drug application...
Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the propellant as the primary source. Since then, Valisure LLC, an independent...
The United States Food and Drug Administration (FDA) is responsible for regulating everything from cosmetic products to medical devices to prescription drugs. In recent years, the FDA has been under enormous pressure to accelerate its...
Johnson & Johnson announced positive results from the VEGA Phase 2 clinical trial that paired the monoclonal antibody Tremfya (guselkumab) and the immunosuppressive drug Simponi (golimumab). The...
On August 31, 2022, the FDA approved Moderna and Pfizer Bivalent COVID boosters to replace the previously available monovalent boosters. Since then, the CDC and other public health organizations have...
In a recent press release, Santen announced that the FDA approved OMLONTI, the company’s newest ophthalmic medication. This ophthalmic solution is composed of 0.002% omidenepag isopropyl. This...
The National Institute of Neurological Disorders and Stroke, a subset of the NIH, estimates that nearly one million people in the United States have Parkinson’s disease. Considering the ever-aging population and the increased risk of...
Yesterday, the FDA approved Relyvrio, an ALS drug developed by Amylyx Pharmaceuticals, after extensive discussions about the safety and efficacy of the drug. The drug was initially rejected by an FDA...
Monday, Boston pharmaceutical company Biogen agreed to pay $900 million to settle a case where it was accused of offering illegal programs that induced physicians to prescribe the drugs Avonex,...
Psilocybin has become increasingly popular in pharmaceutical research to treat multiple neurological and mental health conditions. The FDA recently approved an investigational new drug (IND)...
The FDA approval process is complex and involves multiple steps. Understanding how a prescription drug becomes available over the counter (OTC) is essential for healthcare professionals, members of the pharmaceutical industry, and...
The FDA approval process is multi-faceted and involves several aspects. One of these aspects is accelerated approval, which is meant to approve drugs to treat severe or fatal diseases. According to a...
Results from the Phase III CodeBreaK 200 clinical trial found that Amgen’s targeted therapy Lumakras successfully extended progression-free survival (PFS) by about two months and was 15% more...
A retrospective cohort study was conducted using data from January 1, 2004, to December 31, 2018. The researchers reviewed information from the FDA and the European Medicines Agency (EMA) to determine...
