WWE Superstars visited children participating in clinical trials at the NIH Clinical Center and The Children’s Inn, providing a morale boost and raising awareness for pediatric research. This event highlights the importance of community support in clinical research.

A recent NIH clinical trial demonstrates a 94% survival rate for severe aplastic anemia patients receiving expanded umbilical cord blood transplants. This breakthrough offers hope for individuals with this life-threatening condition who have limited treatment options.

The U.S. Food and Drug Administration recently approved two new oral medicines to treat a common sexually transmitted infection called gonorrhea.

EMA announces a significant overhaul of EU pharmaceutical legislation, aiming to modernize drug development and authorization processes. Key regulations affecting rare diseases will be impacted, with assessment times reduced from 210 to 180 days, enhancing patient and healthcare professional representation.

Regla María Garci Espejo shares her personal story of growing up with a sister affected by West syndrome, a severe early-onset epilepsy. This narrative highlights the challenges faced by families dealing with rare diseases and aims to raise awareness.

The EMA's CHMP recommended seven new medicines for approval during its December 2025 meeting. This highlights ongoing advancements in the pharmaceutical pipeline, although specific drug names and indications were not disclosed.

EMA recommends conditional marketing authorization for Anktiva (nogapendekin alfa inbakicept) to treat adults with non-muscle invasive bladder cancer. This decision could significantly impact treatment options for this patient population in the EU.

The NIH has implemented a new policy to enhance security measures for human biospecimens funded by NIH, aligning with Executive Order 14117. This policy aims to protect human participants and safeguard national security interests.

The FDA has withdrawn approval for 20 abbreviated new drug applications (ANDAs) from various applicants, including Pfizer and King Pharmaceuticals, due to the products no longer being marketed. This decision reflects ongoing regulatory oversight in the pharmaceutical industry.

The FDA is seeking input from stakeholders, including patient advocacy groups, for the reauthorization of the Biosimilar User Fee Act (BsUFA), which is set to expire in September 2027. This consultation is crucial for the future collection of user fees for biosimilar products.

The FDA has proposed an amendment to Over-the-Counter Monograph M020 regarding sunscreen drug products. This proposed order aims to enhance regulations for sunscreen products available for human use.

The FDA has confirmed that LUNELLE (estradiol cypionate and medroxyprogesterone acetate) was not withdrawn for safety or effectiveness reasons. This decision paves the way for the approval of abbreviated new drug applications for this injectable formulation.

The FDA has confirmed that DEMEROL (Meperidine Hydrochloride) and other drug products were not withdrawn for safety or effectiveness reasons. This decision allows the continued approval of abbreviated new drug applications (ANDAs) for these products, ensuring their availability in the market.

The FDA confirms that BACTROBAN (mupirocin) nasal ointment, 2%, was not withdrawn for safety or effectiveness reasons, paving the way for the approval of abbreviated new drug applications (ANDAs). This decision supports market access for generic versions of the drug.

The FDA confirms that ZANTAC (ranitidine hydrochloride) injection has not been withdrawn from sale due to safety or effectiveness concerns. This decision allows for continued manufacturing as long as it meets acceptable nitrosamine impurity limits.