• Milestone Pharmaceuticals won its first FDA approval after overcoming key clinical and regulatory hurdles to develop a fast-acting nasal spray for a heart condition.
• Eli Lilly reported its experimental obesity drug helped people lose more weight than existing treatments and eased arthritis symptoms.
• Novartis said its experimental drug ianalumab helped control an autoimmune disease that causes low platelet counts in a Phase 3 trial by targeting faulty immune cells.

Recent News

• Under Fire: The Hep B Vaccine Explained
  Biotech Primer – December 16, 2025
  A surprising move by the federal vaccine panel has sparked a heated conversation over a vaccine that’s quietly saved over a million babies from hospitalization for more than 4 decades. The hepatitis B vaccine is one of the least controversial, most effective tools in modern medicine, so seeing it suddenly debated feels a bit like questioning your umbrella after it kept you dry. And yet, here we are—revisiting a public-health success story that has long been considered settled science.
• AZ, Daiichi score with FDA nod for Enhertu combo in 1st-line breast cancer
  Fierce Pharma – December 15, 2025
  After AstraZeneca and Daiichi Sankyo made waves in June with eye-opening results for Enhertu in a combination treatment for a particular type of breast cancer, the companies have scored an FDA approval in the indication. The U.S. regulator has signed off on Enhertu combined with Roche’s Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer as confirmed by an FDA-approved test. The FDA originally approved antibody-drug conjugate Enhertu in 2019 as a third-line treatment in the indication, then upgraded the nod to second-line use in 2022.
• Milestone wins first-ever FDA approval with green light for heart arrhythmia nasal spray
  Fierce Pharma – December 15, 2025
  Clearing clinical and regulatory hurdles in the development of a fast-acting nasal spray for a heart condition has given Milestone Pharmaceuticals its first FDA approval in its 22-year history. The U.S. regulator has signed off on Cardamyst (etripamil) to quell symptomatic episodes from paroxysmal supraventricular tachycardia (PSVT), which is a type of abnormal heart rhythm. Cardamyst becomes the first self-administered treatment patients can use to manage their PSVT symptoms.
• Kyverna to seek first clearance of a CAR-T therapy for autoimmune disease
  Biopharma Dive – December 15, 2015
  Kyverna has long been a front-runner in the race to transform the types of cell therapies originally developed for cancer into autoimmune disease treatments. Originally formed to pursue so-called Treg cell therapy, Kyverna changed direction and licensed a more conventional cell therapy technology that’s yielded what’s now known as miv-cel. Fueled by academic studies suggesting these therapies might rewire the immune systems of people with autoimmune disorders like lupus, it raised hundreds of millions of dollars in private and public funding. But mixed early results and growing competition tempered excitement about these treatments, depressing the share price of Kyverna and many of its peers.
• AC Immune posts positive data for Parkinson’s immunotherapy
  Biopharma Dive – December 11, 2025
  Shares of Swiss drugmaker AC Immune rose by double-digits after the company reported positive data from a clinical trial testing its experimental vaccine for Parkinson’s disease. The vaccine is designed to spur the immune system to produce certain antibodies that can both break up and stop the spread of toxic clumps of “alpha-synuclein,” a protein closely linked to Parkinson’s. An ongoing, mid-stage trial has enrolled around 150 people at early stages of the disease, and is comparing three different doses of the immunotherapy against a placebo over a main study period of a year and a half.
• Major Weight Loss and Knee-Pain Relief Seen With New Eli Lilly Drug
  The New York Times – December 11, 2025
  People with obesity and arthritis taking an experimental obesity drug made by Eli Lilly lost more weight than with any drug now on the market, and they reported relief from their arthritis symptoms, the company announced. The drug, retatrutide, is a next-generation obesity and diabetes medication from Eli Lilly, which already sells Mounjaro for diabetes and Zepbound for weight loss. These drugs catapulted Lilly in November into becoming the first medical company to hit a trillion-dollar valuation. Arthritis experts said they were impressed by the effects of retatrutide on knee pain, especially added to the significant weight loss in participants.
• Novartis notches another win for drug acquired in MorphoSys deal
  Biopharma Dive – December 9, 2025
  An experimental Novartis drug helped bring an autoimmune condition causing low platelet counts under control in a Phase 3 trial, further lifting the prospects of a therapy the company acquired in a multibillion-dollar deal last year. The drug, ianalumab, acts by destroying misfiring immune cells and blocking signaling that creates new ones. Novartis has been testing it in a disorder called immune thrombocytopenia, in which the body erroneously wipes out blood-clotting platelets. The company intends for the drug to work hand-in-hand with another therapy, Promacta, that it sells for the condition.
• Vertex CRISPR therapy hits early goal in children with blood disorders
  Biopharma Dive – December 6, 2025
  Vertex Pharmaceuticals’ genetic medicine Casgevy hit an early goal in two late-stage trials focused on children with uncommon blood disorders, helping them avoid damaging vessel blockages and the need for transfusions in a setting expected to be among the first to receive an extra-speedy review from the Food and Drug Administration. The data, disclosed Saturday at the American Society of Hematology scientific meeting in Orlando, may help boost disappointing sales for Casgevy, the first therapeutic to use CRISPR gene-editing technology to modify human diseases.
• Bio Meets Tech: How Amgen is Designing the Medicines of Tomorrow
  Amgen – December 2, 2025
  At Amgen, science has always been about pushing boundaries. From pioneering recombinant protein therapies in the 1980s to today’s advanced biologics, Amgen researchers have embraced new tools to deliver for patients. Today, artificial intelligence (AI) is the latest tool transforming ways of working—enhancing, not replacing, the role of scientists. By merging biology, AI and automation, Amgen researchers are moving beyond discovery to designing biologic medicines with precision and intent.