AbbVie Submits FDA Application for Etentamig in Relapsed or Refractory Multiple Myeloma

–  Etentamig is a second-generation BCMA-directed bispecific antibody T-cell engager with a clinical profile and dosing schedule that can pote...

October 29, 2026 | Thursday | News
Cognition Therapeutics Reaches FDA Agreement on Phase 3 Zervimesine Trial for Lewy Body Dementia

Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical-stage company developing product candidates that treat neurodegenerativ...

October 23, 2026 | Friday | News
IBA Treats First Patient in Clinical Trial of ConformalFLASH Proton Therapy for Head and Neck Cancer

IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology and the world’s leading provider of proton therapy so...

October 22, 2026 | Thursday | News
FDA Approves GSK and Ionis’ Hibsago for Chronic Hepatitis B Treatment

Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner GSK announced that the U.S. Food and Drug Administration (FDA) has approved Hibsago (bepirovirsen) for t...

October 22, 2026 | Thursday | News
Alvotech Secures FDA Approval for New SIMLANDI Manufacturing Process, Doubling Batch Output

Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worl...

October 21, 2026 | Wednesday | News
FDA Approves Roche’s Enspryng for Adults with Thyroid Eye Disease

FDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement...

October 19, 2026 | Monday | News
FDA Grants Second Fast Track Designation to Marengo’s Invikafusp Alfa

New designation expands on first Fast Track Designation in TMB-H colorectal cancer and is supported by monotherapy responses across m...

October 16, 2026 | Friday | News
FDA Clears ArkBio’s AK0406 for Phase 2 Influenza Prevention Study

Shanghai Ark Biopharmaceutical Co., Ltd. ("ArkBio")  announced that the U.S. Food and Drug Administration (FDA) has granted its investigational new dr...

October 14, 2026 | Wednesday | News
Foresee’s CAMCEVI Wins NMPA Approval in Advanced Prostate Cancer

Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") announced that it was notified by its licensing partner, Changchun GeneScience Pharmaceutical Co., Ltd. (...

October 13, 2026 | Tuesday | News
FDA Grants Fast Track Status to Leads Biolabs’ Opamtistomig in Biliary Tract Cancer

Nanjing Leads Biolabs Co., Ltd. (“Leads Biolabs” or the “Company,” Stock Code: 9887.HK) announced that the U.S. Food and Drug Admin...

October 13, 2026 | Tuesday | News
FDA Approves Tecentriq Combination for Stage III dMMR Colon Cancer

FDA approval is based on results from the landmark Phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plu...

October 12, 2026 | Monday | News
FDA Accepts Bayer’s KERENDIA Application for CKD Without Diabetes

The supplemental New Drug Application (sNDA) was supported by results from the Phase III FIND-CKD trial investigating KERENDIA® (finerenone) in adult...

October 09, 2026 | Friday | News
Cerevance Reports Positive Phase 3 Results for Solengepras in Parkinson’s Disease

Solengepras 150 mg achieved a statistically significant reduction in daily OFF time, with benefit seen at Week 2 Statistically significant improvements ...

October 08, 2026 | Thursday | News
Replimune Launches TUDRIQEV in US for Advanced Melanoma Following FDA Approval

Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, announced tha...

October 05, 2026 | Monday | News

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