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2026
Pharma News, 2026
FDA Approves AstraZeneca's Calquence Plus Venetoclax for CLL Treatment
FDA approves AstraZeneca's Calquence plus venetoclax as the first all-oral, fixed-duration regimen for first-line chronic lymphocytic leukemia treatment.
Preclinical Drug Rytvela Blocks Preterm Birth, Outperforming Nifedipine
New preclinical data shows the anti-inflammatory drug Rytvela decreases preterm birth and infant mortality by targeting IL-1ß without immune suppression.
WHO Urges Development of Universal Influenza Vaccines to Save Millions
WHO highlights the need for universal flu vaccines to prevent 18 billion cases and save 6.2 million lives amid evolving pipeline and US regulatory shifts.
Clinical Trial: Dexamethasone Safe in Encephalitis, Early Use May Help
DexEnceph trial finds dexamethasone safe for HSV encephalitis. While overall outcomes didn't change, early use showed promise. Published in Lancet.
ExCellThera's Zemcelpro Grants German NUB Status 1 for Stem Cell Transplant
ExCellThera and Cordex Biologics receive NUB Status 1 in Germany for Zemcelpro. The stem cell therapy aids blood cancer patients lacking donor cells.
PTC Withdraws Translarna NDA for Duchenne Muscular Dystrophy in the US
PTC withdraws Translarna NDA for DMD after FDA cites lack of efficacy evidence. This marks the third failed US approval attempt for the therapy.
Cue Biopharma Reports Positive Safety Data for Autoimmune Drug CUE-401
Cue Biopharma announces positive preclinical safety and tolerability data for CUE-401, a novel biologic for autoimmune and inflammatory diseases.
Alkem’s Enzene Unit Gets USFDA Form 483: 6 Observations, No Data Issues
Alkem Laboratories says subsidiary Enzene Biosciences received a Form 483 with 6 procedural observations from USFDA. No data integrity issues found.
Clinical Trials: Nitrous Oxide Offers Hope for Treatment-Resistant Depression
Researchers find nitrous oxide effective for treatment-resistant depression. Multiple doses show sustained improvement in new eBioMedicine study.
Ampersand Capital Acquires Purna Pharmaceuticals: Trans-Atlantic CDMO Deal
Ampersand Capital acquires Purna Pharmaceuticals to build a trans-Atlantic CDMO partnership with MedPharm for liquid and semi-solid drug development.
EC Approves Amgen’s Uplizna for Generalized Myasthenia Gravis Treatment
EC approves Amgen's Uplizna for generalized myasthenia gravis. A new B-cell therapy with twice-yearly dosing for AChR+ and MuSK+ antibody patients.
FDA Grants Orphan Drug Designation to HCB101 for Gastric Cancer Treatment
FDA grants Orphan Drug Designation to HCB101 for gastric cancer. Phase 1b/2a data shows 100% disease control rate in specific efficacy cohorts.
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