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BMS and 2seventy Bio’s Abecma Faces FDA Review Extension
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The US Food and Drug Administration (FDA) has postponed the target action date for Bristol Myers Squibb (BMS; NYSE: BMY) and 2seventy Bio (NASDAQ: TSVT)’s CAR-T cell therapy Abecma (idecabtagene vicleucel) from December 16. The decision affects the therapy’s filing for earlier lines of triple-class exposed relapsed or refractory multiple…
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BeiGene’s Brukinsa Secures Additional EU Approval for Follicular Lymphoma Treatment
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BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has achieved its latest global approval for the Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib). The European Commission has approved Brukinsa in combination with obinutuzumab (Roche’s CD20-targeted Gazyva) as a third-line treatment for relapsed or refractory (R/R) follicular lymphoma (FL). This marks…
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Ascentage Pharma Secures Additional Indication Approval for Olverembatinib from NMPA
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China-based Ascentage Pharma (HKG: 6855) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Category 1 drug, olverembatinib. This second market-approved indication is for the treatment of adult patients with chronic myeloid leukemia (CML) in the chronic phase (CP) who are resistant and/or intolerant…
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Apollomics’ Partner Avistone Wins Conditional Approval for c-Met Inhibitor in China
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US-based biotech Apollomics Inc., (NASDAQ: APLM) has announced that its Chinese partner, Avistone Biotechnology Co., Ltd, has received conditional market approval for the c-Met inhibitor vebreltinib from the National Medical Products Administration (NMPA). The approval is for the treatment of patients with MET exon 14 skipping non-small cell lung cancer…
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Pfizer and Astellas Pharma Secure FDA Approval for Xtandi in High-Risk Non-Metastatic Prostate Cancer
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Partners Pfizer (NYSE: PFE) and Astellas Pharma (TSE: 4503) last week received indication extension approval from the US Food and Drug Administration (FDA) for their androgen receptor signaling inhibitor Xtandi (enzalutamide). The drug is now approved as a treatment for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high…
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Yifan Pharmaceutical’s Subsidiary Receives FDA Approval for Ryzneuta (F-627)
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd., has received Biologic License Application (BLA) approval from the US Food and Drug Administration (FDA) for Ryzneuta (efbemalenograstim alfa, F-627). The drug is indicated to reduce the incidence of infection manifested as febrile neutropenia in…
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AstraZeneca Receives FDA Approval for Truqap in HR-Positive, HER2-Negative Breast Cancer
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UK-based pharmaceutical company AstraZeneca (AZ; NASDAQ: AZN) announced last week that it has received regulatory approval from the US Food and Drug Administration (FDA) for its first-in-class AKT inhibitor, Truqap (capivasertib), in combination with fulvestrant. This treatment is indicated for HR-positive, HER2-negative locally advanced or metastatic recurrent or refractory breast…
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BMS’s Augtyro Receives FDA Approval for ROS1-Positive NSCLC
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS, NYSE: BMY) registration approval for its next-generation tyrosine kinase inhibitor (TKI) Augtyro (repotrectinib) for the treatment of locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) in adults. This decision follows a priority review of Phase…
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Easton Pharmaceutical Receives FDA Approval for Generic Nalmefene
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Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced receiving Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Hikma Pharma’s (LON: HIK) Revex (nalmefene). Nalmefene is utilized to reverse the effects of opioid drugs, including respiratory suppression caused by…
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Vertex Pharmaceuticals and CRISPR Therapeutics Receive Conditional Approval for CRISPR Gene-Editing Therapy
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Vertex Pharmaceuticals (NASDAQ: VRTX) and CRISPR Therapeutics (NASDAQ: CRSP) have received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for their jointly developed therapy, Casgevy (exagamglogene autotemcel), a treatment for sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) and for transfusion-dependent beta thalassemia (TDT) in…
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Sino Medical Sciences Technology’s HT Supreme Stent Gains Brazilian Market Approval
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Sino Medical Sciences Technology Inc., (SHA: 688108) a leading China-based medical device company, has announced that its HT Supreme drug-eluting stent system has received market approval in Brazil. This system is designed to improve the diameter of the coronary artery lumen in patients suffering from symptomatic heart disease caused by…
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EMA’s CHMP Issues Positive Opinion for Roche’s Tecentriq SC Subcutaneous Formulation
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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Sansure Biotech Secures CE IVDR Certifications for Chemiluminescence Analyzers in the EU
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China-based molecular diagnostics specialist, Sansure Biotech Inc., (SHA: 688289), has announced that it has received CE IVDR certifications in the European Union for two of its fully automatic chemiluminescence immunoassay analyzer products. This regulatory milestone marks a significant step forward for the company in expanding its presence in the EU…
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Servier’s Tibsovo Receives FDA Approval for IDH1-Mutated R/R MDS, Expanding Indications
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France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
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AstraZeneca’s Imfinzi Gains NMPA Approval for First-Line Cholangiocarcinoma Treatment
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The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
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China’s NMPA Grants Conditional Approval for Juventas’ CAR-T Therapy Inaticabtagene Autoleucel
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The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
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Eli Lilly’s Zepbound Approved by FDA for Chronic Weight Management in Adults
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Eli Lilly (NYSE: LLY) has received registration approval from the US Food and Drug Administration (FDA) for its once-weekly injection Zepbound (tirzepatide). The drug is indicated as an adjunct to diet and exercise for chronic weight management in adults with obesity or overweight conditions, including those with at least one…
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Sino Medical Sciences Technology Secures EU MDR Approval for HT Supreme Drug-Eluting Stent System
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China-based Sino Medical Sciences Technology Inc., (SHA: 688108) has announced that it has received Medical Device Regulation (MDR) approval in the European Union for its HT Supreme drug-eluting stent system. Features of the HT Supreme Drug-Coated Coronary Artery Stent SystemThe HT Supreme drug-coated coronary artery stent system is a combination…
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Roche’s Lymphoma Therapy Columvi Receives NMPA Approval for Adult Patients with Relapsed DLBCL
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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Lifetech Scientific Corporation Receives NMPA Approval for Peripheral Thrombus Suction Catheter
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Lifetech Scientific Corporation (HKG: 1302), a China-based medical device company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its innovative peripheral thrombus suction catheter. This device is designed for the removal of thrombi from the peripheral arterial and venous vascular systems, offering…
