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Daiichi Sankyo’s Datroway Approved in Japan for HR+, HER2- Breast Cancer
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Japan-based pharmaceutical company Daiichi Sankyo (TYO: 4568) has announced that it has received marketing approval in Japan for its datopotamab deruxtecan, to be sold under the commercial name Datroway. Datroway is indicated for the treatment of adult patients with hormone receptor (HR) positive, HER2 negative unresectable or recurrent breast cancer,…
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MabPharm’s CMAB807 Biosimilar Receives Market Approval in Indonesia and Peru
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Taizhou-based MabPharm Ltd (HKG: 2181), a specialist in monoclonal antibody (mAb) biosimilars, has announced the receipt of market approval for CMAB807, a biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) Remicade (infliximab), in Indonesia, with a similar approval in Peru in July this year. The approval encompasses all six…
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BeiGene’s Tevimbra Receives FDA Approval for HER2-Negative Gastric Cancer Treatment
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China-based biopharmaceutical company BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that the US Food and Drug Administration (FDA) has granted another indication approval for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). This new approval allows the use of tislelizumab in combination with platinum and fluoropyrimidine-based chemotherapy to…
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Bristol-Myers Squibb’s Opdivo Qvantig Receives FDA Approval for Expanded Indications
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy). This combination product pairs nivolumab with recombinant human hyaluronidase (rHuPH20) and is set to be used in most previously approved adult solid…
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Advaccine Biotechnology’s MICROEPAD Receives FDA Registration Approval
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China-based vaccine developer Advaccine Biotechnology has announced receiving registration approval from the US Food and Drug Administration (FDA) for its soluble microneedle drug, MICROEPAD. MICROEPAD: A Revolutionary Approach to Skin TreatmentsMICROEPAD, or Dissolvable Microneedle Blemish Patches, is an over-the-counter (OTC) medication designed to treat acne, acne scars, and blackheads, promoting…
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Hybio Pharmaceutical Receives US FDA Approval for Biosimilar Victoza (Liraglutide)
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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RaysightMed’s AngioQFA 100 Receives NMPA Approval for Coronary Artery Function Measurement
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China-based RaysightMed Co., Ltd has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its next-generation FFR imaging product, AngioQFA 100, a revolutionary coronary artery function measurement system. Advanced Fusion Technology for Comprehensive AssessmentThe AngioQFA 100 system employs a sophisticated fusion of artificial intelligence…
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Keymed Biosciences’ Kangyueda Approved for CRSwNP Treatment in China
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China-based Keymed Biosciences Inc., (HKG: 2162) has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its anti-IL-4Rα monoclonal antibody (mAb), Kangyueda (stapokibart), to treat chronic rhinosinusitis with nasal polyposis (CRSwNP). This approval follows the NMPA’s endorsement for moderate to severe atopic dermatitis…
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AstraZeneca’s Tagrisso Secures EU Approval for EGFR-Mutated Locally Advanced NSCLC
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UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that the European Commission (EU) has granted another indication approval for its drug Tagrisso (osimertinib). The approval is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR)…
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Bristol-Myers Squibb’s Opdivo-Yervoy Combo Approved by EC for MSI-H/mCRC
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Global biopharmaceutical company Bristol-Myers Squibb (BMS, NYSE: BMY) has announced that it has received marketing approval from the European Commission (EC) for its combination therapy of Opdivo (nivolumab) and Yervoy (ipilimumab). This treatment is indicated for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient…
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Roche’s Lunsumio Receives NMPA Approval for R/R Follicular Lymphoma Treatment
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its bispecific antibody (BsAb), Lunsumio (mosunetuzumab). This therapy targets CD20 and CD3 and is designed to treat adult patients with recurrent or refractory follicular lymphoma (R/R FL) who…
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Pfizer’s Braftovi Receives FDA Approval for Metastatic Colorectal Cancer Treatment
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US-based Pfizer (NYSE: PFE) has announced receiving an indication extension approval from the US Food and Drug Administration (U.S. FDA) for Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Braftovi’s Existing…
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Eli Lilly’s Zepbound Receives FDA Approval for Moderate-to-Severe OSA and Obesity
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US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has revealed that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Zepbound (tirzepatide), marking it as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound can…
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Novo Nordisk’s Alhemo Receives FDA Approval for Hemophilia A and B Prophylaxis
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for its Alhemo (concizumab-mtci) injection. The drug is indicated as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years…
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Yifan Pharmaceutical’s Evive Biotech Receives ANVISA Approval for Ryzneuta
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd, has received marketing approval from the Brazil National Health Surveillance Agency (ANVISA) for Ryzneuta (efbemalenograstim alfa, F-627). This approval follows previous marketing nods in China, the United States, and the European Union. Ryzneuta (F-627): A…
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Innovent Biologics’ Taletrectinib Wins NMPA Approval for ROS1+ NSCLC Treatment
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its taletrectinib, a second-generation ROS1 tyrosine kinase inhibitor. The drug is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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MicroPort Scientific Corp. Receives NMPA Approval for FireRaptor Coronary Atherectomy System
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Shanghai-based medical device giant MicroPort Scientific Corp. (HKG: 0853) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its FireRaptor coronary rotational atherectomy system. The system includes a rotational atherectomy instrument, disposable coronary artery rotational atherectomy catheter, and rotational atherectomy guide wire. First-Homegrown Coronary Rotational Atherectomy…
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Boston Scientific’s Next-Gen IVUS System AVVIGO+ Approved by China’s NMPA for Coronary Disease Use
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US-based Boston Scientific Corporation (NYSE: BSX) has announced that China’s National Medical Products Administration (NMPA) has granted approval for its next-generation intravascular ultrasound (IVUS) diagnostic system, AVVIGO+, for use in diagnosing coronary heart disease. This marks a significant advancement in the diagnostic capabilities for cardiovascular healthcare in China. Multimodal Platform…
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DaAn Gene Co., Ltd Receives NMPA Approval for Genetic Deafness Gene Detection Kit
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China-based DaAn Gene Co., Ltd, (SHE: 002030) affiliated with Sun Yat-sen University, has announced that it has received a Category III medical device license from the National Medical Products Administration (NMPA) for its genetic deafness gene detection kit, which employs PCR flow cytometry fluorescence hybridization methodology. Advanced Technology for Genetic…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
