The FDA approved 46 novel drugs in 2025, with 70% receiving approval in the United States before any other country, according to a report from the Center for Drug Evaluation and Research (CDER). Several drugs are scheduled for FDA review this February. Will they pass the regulatory muster, or will they be sent back to the drawing board?
A pair of long-term studies has found that the consumption of common food preservatives is linked to cancer and type 2 diabetes. The NutriNet-Santé study in France was conducted among more than 100,000 participants without prevalent cancer over a period of 14 years. Researchers found that six of the 17 preservatives consumed by the participants were linked to cancer. The suspected carcinogenic
A research conducted at the International Space Station has yielded early insights regarding the structure and size of particles best suited for the development of a cancer medicine. In collaboration with scientists at Merck, protein crystal growth research in space gave input regarding the structure and size of particles ideal for developing a new formulation of the company's cancer medicine pem
The regulatory landscape saw several historic firsts in terms of FDA approval in December. Among them are the approval of the first CAR T-cell therapy for marginal zone lymphoma and the introduction of TEMPO, a first-of-its-kind digital health pilot, to name a few. Let's take a look at the key regulatory decisions and anticipated approvals slated for January 2026.
As we enter the final month of the year, it is a good time to review the biotech and pharmaceutical companies with drug candidates pending FDA decisions and see what's ahead on the regulatory front this December.
November, a month best known for Thanksgiving and harvest festivals, is also an important month for raising awareness about various health issues. As we shift our focus to the regulatory front, promising new therapies are awaiting the FDA's verdict this November.
Regeneron Pharmaceuticals Inc. (REGN) is seeking to expand the label of Libtayo as adjuvant therapy in patients with high-risk cutaneous squamous cell carcinoma after surgery, and a decision is expected in October 2025.
As we head into September, the final month of the third quarter, it's time to take a closer look at the biotech and pharmaceutical companies with drug candidates awaiting FDA decisions.
The FDA decision on PharmaTher Holdings' resubmitted Abbreviated New Drug Application for racemic ketamine KETARX is due on August 9, 2025.
July is observed as Sarcoma Awareness Month. Sarcoma is a rare type of cancer that affects muscles, fat, nerves, and other connective tissues. As we get ready to welcome July, it's also time to track the important FDA decisions lined up for the month.
As May draws to a close, it's time to turn our attention to the FDA's upcoming slate of decisions. The following biotech companies are awaiting potential approvals in June 2025.
May has just begun, and it's time to turn our attention to the FDA decisions on deck for the coming weeks.
April is recognized for various health awareness campaigns, and one of them is Autism Awareness Month. According to the most recent data from the CDC, approximately 1 in 36 children are diagnosed with autism spectrum disorder (ASD), a neurodevelopmental condition marked by difficulties in social interaction, communication, and repetitive behaviors.
March is recognized as Awareness Month for several diseases, including Colorectal Cancer, Cerebral Palsy, Deep Vein Thrombosis, Endometriosis, Essential Tremor, Kidney Cancer, Multiple Sclerosis, and others.
January 30, 2026 15:51 ET The Federal Reserve policy decision was the main event in the final week of January, which saw a heavy flow of economics news. Several data reflecting the trends in the U.S. economy were also released during the week. The interest rate decision from Canada also was in focus. In Europe, economic sentiment data gained attention. The policy decision from Singapore was the highlight in Asia.