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Drug Approval

Insilico Medicine Partners With Qilu Pharmaceutical Group To Advance AI Driven Cardiometabolic Drug Discovery

Insilico Medicine, a clinical-stage biotechnology company powered by generative AI, and Qilu Pharmaceutical Group, a major comprehensive modern pharmaceuti...

January 29, 2026 | News

Hanmi Pharmaceutical Advances Global GLP 1 Strategy With Mexico Distribution Agreement For Efpeglenatide

Hanmi is accelerating its global market entry with efpeglenatide, Korea's first domestically developed GLP-1 class obesity and metabolic disease ...

January 29, 2026 | News

Nuance Pharma’s Ohtuvayre NDA Accepted For Review In China For COPD Maintenance Treatment

Nuance Pharma announced that the National Medical Products Administration (NMPA) of China has officially accepted for review the New Drug Application (NDA)...

January 28, 2026 | News

China Approves First Ever Therapy For Chronic Hepatitis D With Conditional Clearance For Libevitug

Huahui Health announced that China's National Medical Products Administration (NMPA) has granted conditional approval to its Libevitug injection for chroni...

January 28, 2026 | News

Innovent’s Tri Specific Antibody IBI3003 Secures US FDA Fast Track Designation In Relapsed Or Refractory Multiple Myeloma

Innovent Biologics, Inc. , a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment...

January 28, 2026 | Report

Merz Therapeutics Submits XEOMIN For Paediatric Spasticity Indication Across Europe

Merz Therapeutics, a leading player in neurology-focused specialty pharma, announced that it has completed the regulatory submission for XEOMIN®&...

January 27, 2026 | News

Insilico Medicine Receives US FDA IND Clearance For AI Designed NLRP3 Inhibitor ISM8969 In Parkinson’s Disease

Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) paves the way for ISM8969 clinical study in the United Stat...

January 26, 2026 | News

FluoGuide Submits FDA IND for FG001, Paving Way for First US Registration Trial in High Grade Glioma

FluoGuide A/S (“FluoGuide” or the “Company”), a biotech company maximizing surgical outcomes in oncology by lighting up cancer...

January 23, 2026 | News

SK Bioscience Advances Zaire Ebolavirus Vaccine Development With CEPI Backed Global Collaboration

SK bioscience announced that it is advancing the development of a Zaire ebolavirus vaccine under a new collaboration supported by the Coalition for Epidemi...

January 23, 2026 | News

Gene Solutions And Pangea Laboratory Partner To Advance US Clinical Validation Of Liquid Biopsy Tests

Insilico Medicine and Hygtia Therapeutics, an incubatee of Shenzhen Pengfu Fund of Fosun Health Capital and Fosun Pharma, have entered into an exclusive ...

January 22, 2026 | News

Ascletis Selects Once Monthly Triple Agonist ASC37 As Clinical Development Candidate For Obesity

- In head-to-head non-human primate (NHP) studies, average observed half-life of ASC37 was approximately 17 days, 7-fold longer than retatrutide, whic...

January 21, 2026 | News

D3 Bio Secures FDA IND Clearances To Advance KRAS G12D And G12C Clinical Programme

D3 Bio, a global clinical‑stage biotechnology company focused on developing transformative oncology therapeutics, announced that the U.S. Foo...

January 20, 2026 | News

Hyundai BioScience Sets Out A Pre Emptive Antiviral Play To Tackle Multiple Viruses With One Drug

- UCSD's Dr. Davey Smith, former ACTIV-2 Protocol Chair, endorses 'Xafty' as "The weapon to end the virus war." - Announces "One Drug, Two Tracks...

January 19, 2026 | News

Kelun Biotech Articulates Global Innovation Vision At J P Morgan Healthcare Conference

From January 12 to 15, 2026, the 44th J.P. Morgan Healthcare Conference (JPMHC) was held in San Francisco, California, USA. Dr. Ge Michael, President and C...

January 19, 2026 | News

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