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BioPharma Drug Approval

Everest Medicines Closes Global Civorebrutinib Licensing Deal Worth Up to $1.14 Billion

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, a...

July 09, 2026 | News

Insilico Medicine Advances AI-Discovered IPF Drug Rentosertib into Phase III Trial

Potentially first-in-class oral TNIK inhibitor advances into late-stage development after milestones marked by vital peer-reviewed papers: the discovery-...

July 09, 2026 | News

Ascletis Files Dual US INDs for Ultra-Long-Acting Obesity Therapies Targeting Amylin, GLP-1 and GIP Receptors

ASC36_35 FDC, a once-monthly subcutaneous (SQ) injection co-formulation of ASC36 and ASC35, is a potentially first-in-class drug candidate targeting thre...

July 07, 2026 | News

Ever Supreme Advances Off-the-Shelf CAR-T Therapy CAR001 to Phase IIa After Positive Phase I Safety Review

Ever Supreme Bio Technology Co., Ltd. (TWSE: 6712) announced on June 28 that CAR001, its proprietarily developed, allogeneic, "off-the-shelf" CAR...

July 01, 2026 | News

NS Pharma Parent Nippon Shinyaku Secures Global Option Rights to Develop Elixirgen's DMD Therapy EXG-7001

NS Pharma, Inc. (NS Pharma; Headquarters, Paramus, NJ; President, Yukiteru Sugiyama) announced that its parent company, Nippon Shinyaku Co., Ltd. (Nippon S...

June 30, 2026 | News

Anivive Wins Full U.S. FDA Approval for Laverdia, First At-Home Oral Treatment for Canine Lymphoma

Anivive converts Laverdia-CA1 to full FDA approval First FDA-approved product to validate Anivive's AI-enabled development model &md...

June 30, 2026 | News

AbbVie Secures U.S. FDA Approval for SKYRIZI in Children with Plaque Psoriasis and Psoriatic Arthritis

SKYRIZI (risankizumab-rzaa) is now approved for patients six years of age and older with moderate-to-severe plaque psoriasis or activ...

June 30, 2026 | News

CStone Partners with Arrotex to Commercialize Sugemalimab in Australia and New Zealand

Arrotex, the pharmaceutical commercialization platform of DBG, Australia's leading diversified healthcare group, will be responsible for the registration...

June 29, 2026 | News

Everest Medicines' LEROCHOL® BLA Accepted in China for Third-Generation PCSK9 Inhibitor

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing an...

June 29, 2026 | News

AnHorn Medicines Secures FDA IND Clearance for First-in-Class CIPN Prevention Candidate

AnHorn Medicines announced that its lead neuroprotective candidate AH-008, being developed for the prevention of chemotherapy-induced peripheral neuro...

June 24, 2026 | News

Incyte Biosciences Japan Secures Japanese Approval for Minjuvi–Lenalidomide Combination in Relapsed/Refractory DLBCL

Incyte Biosciences Japan G.K. announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Minjuvi® (tafasitamab)...

June 23, 2026 | News

Halia Therapeutics Receives FDA Fast Track Designation for Ofirnoflast in Lower-Risk Myelodysplastic Syndromes

Designation follows Phase 2 data showing durable transfusion independence and multilineage hematological improvement; full results presented at EHA2026 Ha...

June 17, 2026 | News

Agility or Corner-Cutting? Asia's Accelerated-Approval Gamble

On 1 April 2026, Japan's Pharmaceuticals and Medical Devices Agency did something no other major medicines regulator had done before it: from that date, ev...

June 17, 2026 | Analysis

China Approves First-in-Human Trial of Antengene’s ATG-201 for Autoimmune Diseases

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, d...

June 12, 2026 | News

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