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J&J’s Balversa Receives Full FDA Approval for Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has converted the 2019 accelerated approval for Johnson & Johnson’s (J&J; NYSE: JNJ) FGFR kinase inhibitor Balversa (erdafitinib) into a full registration. Balversa is indicated for the treatment of locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 mutations in patients who…
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Uni-Bio Science Group Wins NMPA Nod for Generic Forteo Injection for Osteoporosis
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Hong Kong-listed biopharmaceutical company Uni-Bio Science Group Ltd (HKG: 0690) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Eli Lilly Inc (NYSE: LLY)’s Forteo (teriparatide) injection, indicated for the treatment of osteoporosis in postmenopausal women who are at…
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Sichuan Kelun-Biotech Secures NMPA Nod for Generic Lynparza Equivalent
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), a Chinese pharmaceutical company, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of AstraZeneca (AZ, NASDAQ: AZN)’s PARP inhibitor Lynparza (olaparib). This marks the second approval for a Lynparza generic in China,…
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Sanofi’s Dupixent Receives FDA Label Update for Atopic Dermatitis Patients with Hand or Foot Involvement
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Sanofi (NASDAQ: SNY) has been granted authorization by the US Food and Drug Administration (FDA) to update the label of Dupixent (dupilumab) to include efficacy and safety data for patients aged 12 and older with atopic dermatitis that involves uncontrolled moderate-to-severe hand or foot symptoms. The data from a late-stage…
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Ultrasound Biotechnology Earns FDA Nod for Disposable Endoscopic Ultrasound Probes
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Ultrasound Biotechnology, the Shanghai-based wholly owned subsidiary of US firm Ultrasound Wondering, Inc., has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its “Endoscopic ultrasound diagnostic equipment and disposable sterile endoscopic ultrasound probes” product. This marks a significant milestone as the company…
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FDA Approves Casgevy, the First CRISPR-Based Gene Editing Therapy for β-Thalassemia
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Casgevy (exagamglogene autotemcel), the pioneering gene editing therapy based on CRISPR technology, has received approval from the US Food and Drug Administration (FDA) for the treatment of patients aged 12 and above with transfusion-dependent β-Thalassemia (TDT). This marks a significant milestone as Casgevy becomes the world’s first CRISPR-based gene editing…
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Sino Biopharmaceutical Receives NMPA Approval for Generic Revolade Equivalent
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Sino Biopharmaceutical Ltd (HKG: 1177), a major player in the Chinese pharmaceutical industry, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Novartis’s Revolade (eltrombopag olamine). The drug is indicated for the treatment of adults and children aged six and…
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Takeda’s Hyqvia Approved by FDA for Chronic Inflammatory Demyelinating Polyneuropathy
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Japanese pharmaceutical company Takeda (TYO: 4502) has received an indication extension approval from the US Food and Drug Administration (FDA) for its plasma-derived therapy Hyqvia (human immunoglobulin 10%). The therapy is now approved for use as a maintenance treatment in chronic inflammatory demyelinating polyneuropathy (CIDP). Initially approved in the US…
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Qilu Pharmaceutical’s Iruplinalkib Gains Additional Indication Approval in China for ALK-Positive NSCLC
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The National Medical Products Administration (NMPA) website has indicated that Qilu Pharmaceutical’s Category 1 drug, Iruplinalkib, has received additional indication approval in China. The new indication is for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). Previously approved in China…
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Roche’s Tecentriq SC Receives European Nod as First Subcutaneous PD-(L)1 Therapy
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Halozyme Therapeutics (NASDAQ: HALO) has announced that the European Commission (EC) has granted marketing authorization to Roche (SWX: ROG) for its anti-PD-L1 drug Tecentriq SC (atezolizumab). This subcutaneous formulation utilizes Halozyme’s proprietary hyaluronidase Enhanze (rHuPH20) and is now approved for the same indications as the original intravenous version of Roche’s…
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Yifan Pharmaceutical Wins Nod for Generic Diazoxide Oral Suspension in China
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products for its generic version of German pharmaceutical giant Bayer’s diazoxide oral suspension. This signifies that the drug has successfully passed the generic quality consistency evaluation (GQCE) process…
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3D Medicines Secures Registration for Envafolimab in Macau for Advanced Solid Tumors
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3D Medicines (HKG: 1244), a China-based oncology specialist, has announced the registration of its PD-L1 monoclonal antibody (mAb) envafolimab in Macau. The approval designates envafolimab for the treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. Envafolimab is notable for being the world’s first…
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MSD’s Keytruda Gains FDA Approval for Advanced Cervical Cancer Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has received regulatory approval from the US Food and Drug Administration (FDA) for the use of its anti-PD-1 drug Keytruda (pembrolizumab) in combination with chemoradiotherapy for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 stage III-IVA cervical cancer. This marks…
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BMS’s Mavacamten Used to Treat First Patient with Hypertrophic Cardiomyopathy in Hainan
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Bristol-Myers Squibb (BMS; NYSE: BMY) has announced that the first patient with obstructive hypertrophic cardiomyopathy (oHCM) has been treated using its drug mavacamten at Ruijin Hospital’s Hainan branch. Mavacamten, the world’s first cardiac myosin inhibitor, received approval from the Hainan Medical Products Administration for special entry into the Hainan Bo’ao…
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Lepu Medical Secures NMPA Approval for Innovative Coronary Intravascular Impact Waveguide Tube
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Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003), a China-based provider of cardiovascular disease solutions, has received marketing approval from the National Medical Products Administration (NMPA) for its proprietary disposable coronary intravascular impact waveguide tube. This Category III device is now authorized for use in the pre-treatment and balloon dilation…
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Eli Lilly Secures NMPA Approval for Emgality as Preventive Migraine Treatment in China
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Eli Lilly (NYSE: LLY) has received marketing approval from the National Medical Products Administration (NMPA) for Emgality (galcanezumab) as a preventive treatment for migraines in adults. Emgality, a monoclonal antibody that selectively targets calcitonin gene-related peptide (CGRP), was initially approved by the U.S. FDA in September 2018 for migraine prevention…
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Novartis’s Cosentyx Secures Additional Indication for Psoriatic Arthritis in China
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Swiss pharmaceutical giant Novartis (SWX: NOVN) has announced that its drug Cosentyx (secukinumab), which targets IL-17A, has received an additional indication approval from the National Medical Products Administration (NMPA) in China. The drug is now approved for the treatment of active psoriatic arthritis (PsA), adding to its existing indications in…
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MSD’s Gardasil 9 Receives NMPA Approval for Two-Dose Schedule in Younger Females
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a prominent pharmaceutical company in the U.S., has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) 9-valent vaccine, Gardasil 9. The vaccine is now approved for a two-dose vaccination schedule (0,…
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3SBio Inc. Receives NMPA Approval for OTC Minoxidil Foam for Male Hair Loss Treatment
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3SBio Inc., a leading biopharmaceutical company based in China (HKG: 1530), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its over-the-counter (OTC) drug, a 5% minoxidil foam agent, which is indicated for the treatment of male pattern hair loss and alopecia areata.…
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ShuWen Biotech’s MammaTyper Diagnostic Kit Receives NMPA Approval for Breast Cancer Molecular Classification
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ShuWen Biotech Co., Ltd, a biopharmaceutical company based in Zhejiang, has announced that its MammaTyper diagnostic kit has received market approval from the National Medical Products Administration (NMPA). The kit is intended for use in cases where immunohistochemistry (IHC) results are indeterminate or unsatisfactory, or when the IHC outcome significantly…
