FDA Approves Imdelltra Label Update – Monitoring Time for First Two Doses Cut to 6–8 Hours from 22–24, Easing Delivery of Amgen's First‑in‑Class SCLC Immunotherapy
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FDA Approves Imdelltra Label Update – Monitoring Time for First Two Doses Cut to 6–8 Hours from 22–24, Easing Delivery of Amgen’s First‑in‑Class SCLC Immunotherapy

Amgen (NASDAQ: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved an update to the prescribing information for Imdelltra (tarlatamab), substantially reducing the recommended monitoring time for…

FDA Accepts Takeda's NDA for Zasocitinib with Priority Review – Next‑Generation Oral TYK2 Inhibitor Nears Decision in Moderate‑to‑Severe Plaque Psoriasis
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FDA Accepts Takeda’s NDA for Zasocitinib with Priority Review – Next‑Generation Oral TYK2 Inhibitor Nears Decision in Moderate‑to‑Severe Plaque Psoriasis

NMPA Approves Expanded Indication for Merck's Winrevair (Sotatercept) – First‑in‑Class Activin Signaling Inhibitor Now Covers WHO Functional Class II–IV PAH in China
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NMPA Approves Expanded Indication for Merck’s Winrevair (Sotatercept) – First‑in‑Class Activin Signaling Inhibitor Now Covers WHO Functional Class II–IV PAH in China

Bio‑heart Partners with Shenqi Medical to Commercialize BioHeart Bioabsorbable Stent – Advancing "Interventional Treatment Without Implantation" in China's Coronary Market
CompanyDeals

Bio‑heart Partners with Shenqi Medical to Commercialize BioHeart Bioabsorbable Stent – Advancing “Interventional Treatment Without Implantation” in China’s Coronary Market

Cheplapharm and Sanofi Move to Forge Strategic Partnership – Lovenox/Clexane Anchors 20‑Medicine Portfolio and Three‑Site Transfer in Exchange for 26.4 % Equity Stake
CompanyDeals

Cheplapharm and Sanofi Move to Forge Strategic Partnership – Lovenox/Clexane Anchors 20‑Medicine Portfolio and Three‑Site Transfer in Exchange for 26.4 % Equity Stake

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CSPC Pharmaceutical Launches Phase Ib/II Trial of Novel SYS6090 Fusion Protein for Colorectal Cancer

Sanofi Reports 17.8% Revenue Growth in Q2 2026, Driven by Dupixent and Pharma Launches
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Sanofi Reports 17.8% Revenue Growth in Q2 2026, Driven by Dupixent and Pharma Launches

CompanyDeals

ELI Radiopharma and United Imaging Research Institute Forge Strategic Alliance to Advance Radiopharmaceutical Innovation

DrugMedical Device

NMPA Proposes Framework for Synchronized Development of Anti-Tumor Drugs and Companion Diagnostics

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CSPC Pharmaceutical Launches Phase II Trial of Novel ADC SYS6041 for Recurrent Ovarian Cancer in China

Policy / Regulatory

NMPA Releases 107th Batch of Reference Drugs for Generic Quality Consistency Evaluation, Adding 71 New Specifications

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Qyuns Therapeutics Secures NMPA Approval for QX027N Clinical Trials in COPD and CRSwNP, Announces Global Partnership

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Jinling Pharmaceutical’s Ferric Carboxymaltose Injection Receives NMPA Acceptance for Market Authorization

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Mabwell (Shanghai) Bioscience Secures NMPA Approval for 9MW5211 Clinical Trials in Primary Biliary Cholangitis

CompanyDrug

Nanjing Leads Biolabs Secures NMPA Approval for Opamtistomig (LBL-024) in Metastatic Colorectal Cancer Clinical Trial

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BrightGene’s Generic Tiotropium Bromide Inhalation Spray Gains NMPA Approval as China’s First Domestic COPD Treatment Alternative

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Insilico Medicine’s NLRP3 Inhibitor ISM8969 Secures NMPA IND Approval for Parkinson’s Disease with Global Clinical Trials Underway

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