Recent News

• US FDA approves Merck’s injectable version of blockbuster cancer therapy Keytruda
  Reuters – September 19, 2025
  The U.S. Food and Drug Administration said it has approved a new formulation of Merck’s, opens new tab blockbuster cancer therapy Keytruda that can be administered under the skin, offering a more convenient version of the widely used cancer immunotherapy. The move marks a significant shift in how one of the world’s top-selling cancer immunotherapies can be delivered, potentially improving patient experience and clinic efficiency. The new version, branded as Keytruda Qlex, can be administered in as little as a minute or two depending on dosage, said Nancy Ibach, associate vice president of US Oncology at Merck, compared to IV infusion that typically takes about 30 minutes. Merck said it expects the injectable version to be available in the United States in late September.
• FDA greenlights Stealth Bio’s injection as 1st treatment for Barth syndrome
  Fierce Biotech – September 19, 2025
  After a tumultuous journey filled with delays and rejection, the FDA has approved Stealth BioTherapeutics’ treatment for the ultrarare disease Barth syndrome, marking the peptide as the first therapy for the condition. The FDA gave the green light via its accelerated pathway, according to a release. Stealth’s injection, known as elamipretide, will be sold as Forzinity for the treatment of Barth syndrome, an X-linked genetic disorder that weakens the heart and other muscles. Death rates are highest in the first four years of life, and patients don’t typically live past their 40s. The daily injection can be used for patients weighing at least 60 pounds, according to the approval. The FDA believes that Forzinity will fill a gap in care for a serious disease, and that existing evidence is “reasonably likely to predict patient benefit but does not directly assess the benefit to the patient.”
• Research doesn’t show using Tylenol during pregnancy causes autism. Here are 5 things to know
  PBS News – September 17, 2025
  For years, Tylenol has generally been considered safe for treating pain and fever — even during pregnancy, when doctors discourage patients from using many medications. Doctors might even recommend taking Tylenol for pain or fever during pregnancy, because left untreated, they can pose their own health risks. But recent news reports about the federal government connecting Tylenol to autism have drawn fresh questions about the drug, and concerns. A few things are clear. After years of research, no study has shown that acetaminophen, the main ingredient in Tylenol, causes autism. There’s no known single cause of autism, a neurological condition that influences how someone acts and communicates. But some scientific terms, like “association,” can confuse the issue. There’s some research that says there’s an association between taking acetaminophen during pregnancy and autism. There’s also some research that says there’s not an association.
• Global biotech leaders Amgen and Gilead announcing expansions in California, the #1 state for life sciences
  Office of Governor Gavin Newsom – September 15, 2025
  Governor Gavin Newsom today highlighted major expansions from Amgen and Gilead Sciences that will bring nearly $1.5 billion in investment, thousands of new jobs and continued momentum to California’s biotech sector. These projects strengthen California’s position as a global leader in life sciences, research and innovation. Earlier this month, biotechnology leader Amgen announced a $600 million investment to expand its global headquarters in Thousand Oaks with a new research center. The new development will expand their Ventura County-based workforce of 5,500 and bring together researchers, engineers and scientists from across disciplines to advance the next era of scientific discovery and human health.
• Trying to get a COVID vaccine right now? Here’s what to know
  NPR – September 15, 2025
  If you want a COVID shot, it can be frustrating to try to get one right now. That’s because the Food and Drug Administration has narrowed its approval for this year’s shots to only certain groups: those 65 and older, and people at high risk for developing severe illness from the virus. It’s a major departure from policy in past years, when the vaccines had been approved for anyone 6 months and older. Trump administration health officials argue that most otherwise healthy, younger people have so much immunity that they don’t necessarily need annual boosters anymore. But many doctors’ groups say it’s a good idea to get one to avoid serious illness or spreading it to others who may be high-risk. So the change means you may have to work harder to get a shot.
• Ozempic for cancer? Signs point to potential benefits of GLP-1s in oncology
  BioPharmaDive – September 12, 2025
  What could GLP-1 drugs, known for their powerful weight loss benefits, have to do with oncology? Potentially “everything,” according to Deborah Phippard, chief scientific officer at the clinical research organization Precision for Medicine. Popular drugs like Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound have such versatile effects that they could play a role treating not only diabetes and obesity, but cancer too, Phippard said. “These are some of the most complicated drugs I’ve seen in my career because they do so many things,” Phippard said. The receptor these drugs bind to “is at the top of so many different pathways, and there are so many downstream effects that feed back in.” The U.S. approval of Wegovy for the liver disease metabolic dysfunction-associated steatohepatitis, or MASH, is a testament to the widespread impact a GLP-1 drug might have, as even the Food and Drug Administration acknowledged that the medicine was able to treat the condition through mechanisms that are not “fully understood.”
• FDA Approves Johnson and Johnson’s INLEXZO, First Breakthrough Bladder Cancer Treatment in 40 Years
  OncoDaily – September 10, 2025
  Johnson and Johnson announced the U.S. Food and Drug Administration approved INLEXZO™, a new, potentially practice-changing approach for treating patients with certain types of bladder cancer, addressing the need for additional options following unsuccessful BCG therapy and for patients refusing or ineligible for bladder removal surgery. INLEXZO, previously referred to as TAR-200, is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. INLEXZO™ is designed for patients seeking bladder preservation and is the first and only intravesical drug releasing system to provide extended local delivery of a cancer medication into the bladder.
• Lyell Immunopharma Announces the Initiation of a Phase 3 Head-to-Head CAR T-Cell Therapy Clinical Trial in Aggressive Large B-Cell Lymphoma and Formation of Expert Steering Committee
  Lyell – September 3, 2025
  Lyell Immunopharma, Inc, a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, announced the initiation of PiNACLE – H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial and the formation of a Steering Committee of preeminent lymphoma experts. The trial is evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the 2L setting. Ronde-cel is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for development in patients with R/R LBCL.
• New Approach for Smarter, Safer Cancer Treatment
  UCSF – September 2, 2025
  While reviewing patients’ charts early in the morning, pediatric hematologist-oncologist Christopher Dvorak, MD, used to feel his heart race when he read about a child with blood cancer getting a stem cell transplant. Stem cells are the body’s building block cells that can develop into other cells, such as blood cells. A stem cell transplant — a procedure that replaces unhealthy stem cells with healthy ones — helps increase children’s chances of surviving blood cancers, like leukemia, and other blood-based illnesses. Before a transplant, patients receive chemotherapy and radiation to ‘condition’ their body to accept the new, healthy stem cells. The conditioning eliminates the body’s current stem cells, weakens the immune system, and destroys any remaining cancerous cells. Even so, Chris knew the long-term prognoses for these kids were grim.