FarmaKology-FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

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Dec 09, 2025

Today's Company

Dyne Therapeutics

Dyne Therapeutics is focused on delivering functional improvement for people living with genetically driven neuromuscular diseases. We are developing therapeutics that target muscle and the central nervous system (CNS) to address the root cause of disease. The company is advancing clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and preclinical programs for facioscapulohumeral muscular dystrophy (FSHD) and Pompe disease. At Dyne, we are on a mission to deliver functional improvement for individuals, families and communities.

News

“LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease Included in China’s Commercial Insurance Innovative Drug List

Eisai Co., Ltd. and Biogen Inc. announced today that anti-Aβ protofibril* antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic name: lecanemab), has been included in the “Commercial Insurance Innovative Drug List” (Chinese: 商业健康保险创新药品目录), recently introduced by the National Healthcare Security Administration (NHSA) of China. The inclusion of LEQEMBI in this list marks a meaningful step toward expanding access to early Alzheimer’s Disease (AD) treatment in China.

Boehringer Ingelheim advances next generation triple-agonist peptide for the treatment of obesity into mid-stage development

Boehringer Ingelheim today announced the advancement of BI 3034701, its long‑acting potential first-in-class triple‑agonist peptide, in development for the treatment of obesity. This milestone reflects the company’s strategy to address the global burden of obesity and its interconnected cardiovascular, renal, metabolic (CRM) complications.

FDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic Anemia

The U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA following reduced intensity conditioning and for whom a compatible donor is not available.

SeaBeLife enters into joint development agreement with Unither Pharmaceuticals to formulate and produce ophthalmic drug candidate

SeaBeLife, a biotechnology company developing innovative drug candidates intended to block cellular necrosis, today announces it has signed a joint development agreement with Unither Pharmaceuticals, a French pharmaceutical CDMO with an international footprint, specialized in the development and manufacture of sterile single doses. The agreement will lead to the production of clinical and commercial batches of the topical ophthalmic formulation of the SBL03 drug candidate. SBL03 is intended to treat degenerative disorders of the retina such as geographic atrophy and dry age-related macular degeneration (AMD).

JAX receives an up to $30M contract award to revolutionize drug safety testing with AI-powered “virtual hearts”

Developing new drugs is one of the riskiest and most expensive endeavors in science. The Jackson Laboratory announced a bold initiative to improve that trajectory, powered by an up to $30 million contract from the Advanced Research Projects Agency for Health (ARPA-H) Computational ADME-Tox and Physiology Analysis for Safer Therapeutics (CATALYST) program. CATALYST is led by ARPA-H Health Science Futures Mission Office Acting Deputy Director Andy Kilianski, Ph.D.