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The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recently endorsed the potential approval of Gilead’s (NASDAQ: GILD) repurposed antiviral Veklury (remdesivir) for the treatment of COVID-19 patients with mild-to-severe hepatic impairment. This milestone could position the nucleotide analog as the first COVID-19 treatment authorized…
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The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have…
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Pfizer (NYSE: PFE) has been granted registration authorization by the European Commission (EC) for Litfulo (ritlecitinib), a JAK3/TEC inhibitor, for the treatment of severe alopecia areata in adults and adolescents. This once-daily drug is the first to be approved in the region for this autoimmune disease, including teenage patients. The…
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Juvéderm VOLUMA with Lidocaine, expanding its indications to include nose augmentation procedures. Product Description and BenefitsJuvéderm VOLUMA with Lidocaine is a cross-linked sodium hyaluronate gel designed…
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its innovative navigation and positioning system, the SkyWalker hip and knee joint replacement surgery robot. This marks the first approval of an in-house developed mechanical arm…
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Sandoz (SWX: SDZ), the generic and biosimilar drug maker set to separate from Novartis (NYSE: NVS) next month, has received a positive review from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar. The biosimilar is intended for use in treating HER2-positive…
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the use of Enhertu (trastuzumab deruxtecan), an antibody-drug conjugate (ADC) developed by AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), in the treatment of advanced non-small cell lung…
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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Merck, Sharp & Dohme’s (MSD; NYSE: MRK) anti-PD-1 therapy, Keytruda (pembrolizumab), as an adjuvant treatment for non-small cell lung cancer (NSCLC) in adults who are at a high risk of…
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China-based surgical robot developer Tuodao Medical Technology Co., Ltd has received marketing approval for its percutaneous puncture surgery robot, known as the puncture surgery navigation and positioning system NP100. This approval marks a significant advancement in the field of surgical robotics within the country. Puncture Surgery and Its ChallengesPuncture surgery…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its irinotecan liposome injection. The drug is indicated for the treatment of metastatic pancreatic cancer in patients after gemcitabine treatment and is also used in…
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Singapore-based medical device company Genesis MedTech has announced that it has received market approval in China for its absorbable sutures with antibacterial protection. This milestone marks the company as the first domestic brand to successfully develop such a product, enhancing its position in the medical device market. Innovation in Surgical…
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The European Medicines Agency (EMA) has granted Japan-based Astellas (TYO: 4503) an indication extension approval for its androgen receptor inhibitor Xtandi (enzalutamide). This approval expands the use of Xtandi as a treatment for non-metastatic hormone-sensitive prostate cancer (nmHSPC) in patients with high-risk biochemical recurrence (BCR) who are unsuitable for salvage-radiotherapy.…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Italy’s Recordati’s Carbaglu (carglumic acid). This marks the first approval of such a generic drug in China, offering a treatment for hyperammoniaemia caused…
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The US Food and Drug Administration (FDA) has granted Pfizer (NYSE: PFE) an indication extension for its SARS-CoV-2 Omicron XBB.1.5 single-dose monovalent vaccine, Comirnaty. The vaccine is now approved for individuals aged 12 years and older, in addition to receiving an emergency use authorization (EUA) for children between 6 months…
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced receiving market approval from the National Medical Products Administration (NMPA) for its in-house developed MemoSorb biodegradable patent foramen ovale occluder. This innovative device is now approved for use in patients aged 18 to 60 with…
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US pharmaceutical major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that its programmed drug Keytruda (pembrolizumab) has been approved in China for the treatment of unresectable or metastatic microsatellite highly unstable (MSI-H) or mismatch repair gene deficient (dMMR) advanced solid tumors. This includes colorectal cancer patients who have…
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Luye Pharma Group (HKG: 2186) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its injectable goserelin acetate in microsphere form, trade-named Botawei, for the treatment of breast cancer in premenopausal and perimenopausal women eligible for hormone therapy. Botawei: A Pioneering Treatment for…
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CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, Shanghai JMT Biotechnology Co., Ltd, has received marketing approval from the National Medical Products Administration (NMPA) for narlumosbart (JMT103), an anti-RANKL monoclonal antibody (mAb), to treat giant cell tumors of bone that are inoperable or may lead to severe…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced that it has received marketing approvals from the Ministry of Health, Labour and Welfare of Japan and the Thailand Food and Drug Administration for its Vericor-14 microcatheter. This regulatory clearance marks a significant milestone for the company’s product, which can now…
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China-based Harbin Gloria Pharmaceuticals Co., Ltd (SHE: 002437) has announced that it has received market approval from the National Medical Products Administration (NMPA) for its programmed cell death-1 (PD-1) monoclonal antibody (mAb) zimberelimab. The drug is indicated for the treatment of recurrent or metastatic cervical cancer patients with positive PD-L1…