Curated news and analysis on clinical trials, drug approvals, and medical research.
The FDA has issued draft guidance that may speed approval pathways for rare disease therapies using genome editing technologies, potentially benefiting CRISPR Therapeutics' pipeline of six clinical-stage candidates.
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
Moderna's seasonal influenza vaccine candidate mRNA-1010 receives FDA acceptance after initial refusal, with a PDUFA date set for August 5, 2026. The revised application proposes full approval for adults 50-64 and accelerated approval for those 65 and older.
Regeneron said the FDA accepted its garetosmab BLA for FOP and granted Priority Review, with a decision expected by August 2026. Phase 3 OPTIMA data reported major lesion reductions versus placebo.
Researchers developed a high-throughput method to systematically discover molecular glues that trigger degradation of disease-causing proteins, demonstrating efficacy against a leukemia-associated protein and transforming drug discovery from chance to scalable workflow.
Eli Lilly announced the acquisition of Orna Therapeutics for up to $2.4 billion on February 9, 2026, gaining access to proprietary circular RNA technology and an "in vivo" CAR-T platform for immunology and oncology applications.
Early trial of Rezatapopt shows 20% response rate in advanced cancers with p53 mutations, while researchers identify AMD3100 as potential solution to enable immunotherapy in rare liver cancer.
CAR T-cell therapy is delivering high remission rates for multiple myeloma patients, with improved handoff communication reducing infection risks. FDA-approved BCMA-targeting products show response rates from 72% to 98% in heavily pretreated patients.
The FDA cleared NexEos Bio's IND application to proceed with a Phase II/III trial of NTX-1024 ophthalmic solution for vernal keratoconjunctivitis, following positive results from a 15-patient study in Mexico.
New combination therapies demonstrate improved outcomes in advanced anal and colorectal cancers, with retifanlimab plus chemotherapy approved for anal cancer and onvansertib showing strong efficacy signals in RAS-mutated colorectal cancer.
Researchers at Stanford and Harvard are developing nasal spray vaccines offering broad protection against respiratory infections, with early animal and phase 1 human trials showing safety and potential efficacy.
Researchers at UC San Francisco discovered that exercise triggers liver production of GPLD1, which removes TNAP protein buildup from blood-brain barrier cells, reducing age-related leakiness and cognitive decline.
Lynch syndrome patients gain access to prevention vaccines in clinical trials, while immunotherapy advances depend on universal tumor testing for microsatellite instability. Cancer vaccines are moving from research to clinical reality.
Hyderabad-based CRDMO Sai Life Sciences plans to recruit over 700 scientific, technical, and management professionals during 2026-27, representing a 20% workforce expansion driven by growing global demand for integrated drug discovery and manufacturing services.
Iovance Biotherapeutics reported Q4 2025 revenue of $87 million, beating estimates, while receiving FDA fast-track designation for lifileucel in non-small cell lung cancer and reporting strong sarcoma trial data.
New research from Michigan State University reveals that differences in hormone-regulated monocytes explain why women experience longer-lasting chronic pain than men, with males producing more IL-10 to shut down pain signals.
Oral semaglutide and the newly FDA-approved Wegovy pill are reshaping weight management by eliminating injections. Clinical trials show meaningful weight loss, while companies integrate the medications into subscription wellness programs.
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
Approved gene-editing therapies for sickle cell disease priced at $2.2 million remain out of reach in Africa, where 80% of the world's cases occur, as Uganda launches mandatory newborn screening.
The University of Colorado Anschutz School of Medicine rose to No. 21 nationally with nearly $314 million in NIH funding, while Colorado School of Public Health climbed to No. 17 with over $22 million. Wayne State University School of Medicine ranked 73rd with $61.6 million.
