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Sanofi’s Merilog Biosimilar Wins FDA Approval for Diabetes Treatment
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The U.S. Food and Drug Administration (FDA) has approved Sanofi-Aventis’ (EPA: SAN) Merilog, a biosimilar of Novo Nordisk’s (NYSE: NVO) NovoLog. Merilog, a rapid-acting insulin, is indicated for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus. The approval includes both a 3 milliliter (mL) single-patient-use…
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GSK’s Penmenvy Meningococcal Vaccine Approved by FDA for Ages 10-25
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UK-based multinational GSK plc (LON: GSK) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for use in individuals aged 10 through 25 years. The vaccine targets the five major serogroups of…
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LINDIS Biotech’s Korjuny Approved by European Commission for Malignant Ascites
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Germany-based LINDIS Biotech GmbH announced that it has received market approval from the European Commission (EC) for its Korjuny (catumaxomab), making the trifunctional anti-CD3 x anti-EpCAM antibody (trAb) the only approved therapy for patients with malignant ascites (MA) across Europe. Drug BackgroundCatumaxomab was originally discovered by German firm Trion Pharma…
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SciClone’s Vibativ Approved by NMPA for HABP/VABP Treatment
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China-based SciClone Pharmaceuticals Inc. announced that it has received market approval from the National Medical Products Administration (NMPA). The approval allows its Vibativ (telavancin) to treat hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by sensitive isolates of Staphylococcus aureus. Drug DetailsVibativ is a rapidly bactericidal glycopeptide antibiotic with bactericidal activity…
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Merck’s Zerbaxa Approved by China’s NMPA for Complex Infections
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US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its antibiotic Zerbaxa (ceftolozane, tazobactam). The fixed-dose combination antibiotic medication is approved to treat a range of complex infections in both adult and pediatric…
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Roche’s Evrysdi Tablet Approved by FDA for Spinal Muscular Atrophy
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Swiss giant Roche (SWX: ROG) has announced that it has received marketing approval from the US FDA for its Evrysdi (risdiplam) tablet. The tablet is approved to treat spinal muscular atrophy (SMA) patients aged 2 months and above and weighing over 20 kilograms (44 pounds). Drug DetailsEvrysdi is a survival…
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Pfizer’s Adcetris Gets New FDA Approval for Lymphoma Treatment
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US giant Pfizer (NYSE: PFE) has announced that it has received another indication approval from the US FDA for its Adcetris (brentuximab vedotin). The antibody-drug conjugate (ADC) can now be used in combination with lenalidomide and a rituximab product. It is approved for the treatment of adult patients with relapsed…
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Astellas Pharma’s Izervay Gets FDA Approval for GA Treatment Without Dosing Limit
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Japan-based Astellas Pharma Inc. (TYO: 4503) has announced that the US Food and Drug Administration (FDA) has approved its label extension application for Izervay (avacincaptad pegol intravitreal solution). The approval allows the drug to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD) without any limitation on the duration…
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Bayer’s Acoramidis (Beyonttra) Gets EMA Marketing Approval for ATTR-CM Treatment in EU
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Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for its drug acoramidis, commercially known as Beyonttra. This near-complete (≥90%) transthyretin (TTR) stabilizer can now be used to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) in the European Union (EU).…
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Lifetech Scientific’s Aortic Stent Graft System Wins NMPA Approval
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China-based Lifetech Scientific Corporation (HKG: 1302) announced that it has received market approval from the National Medical Products Administration (NMPA) for its aortic stent graft system, co-developed by Fuwai Hospital. Product OverviewThe aortic stent graft system is the first of its kind in China specifically designed for chimney technology. It…
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MicroPort MedBot’s Toumai Surgical Robot Wins NMPA Approval for Single-Hole Laparoscopy
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Shanghai MicroPort MedBot (Group) Co., Ltd (HKG: 2252) announced that the National Medical Products Administration (NMPA) has granted market approval for its Toumai single-arm single-hole laparoscopic surgical robot. The device is designed to perform minimally invasive surgeries through a single incision, offering clinical benefits such as reduced scarring and faster…
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J&J’s Rybrevant and Talvey Win Separate NMPA Approvals in China
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US pharma giant Johnson & Johnson (J&J, NYSE: JNJ) announced receiving marketing approvals from China’s National Medical Products Administration (NMPA) for two of its biologics: Rybrevant (amivantamab) for non-small cell lung cancer (NSCLC) and Talvey (talquetamab) for multiple myeloma. The approvals mark J&J’s latest expansion in China’s oncology market. Rybrevant…
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China Resources Double-Crane Pharmaceutical Co., Ltd Receives NMPA Approval for Generic Purinethol
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China Resources Double-Crane Pharmaceutical Co., Ltd (SHA: 600062) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Stason Pharmaceuticals Inc.’s Purinethol (mercaptopurine). The drug, classified as a Category 2.2 chemical drug, is now approved for the treatment of children with…
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CSPC Pharmaceutical’s Omalizumab Biosimilar Wins NMPA Approval for Allergic Asthma
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has received an additional indication approval from the National Medical Products Administration (NMPA) for its biosimilar version of Novartis’ Xolair (omalizumab), an anti-human immunoglobulin E (IgE) monoclonal antibody (mAb). The latest approval is for the treatment of moderate to severe persistent allergic asthma,…
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Sinopep-Allsino Wins NMPA Approval for Generic Liptruzet in China
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Jiangsu-based CDMO Sinopep-Allsino Biopharmaceutical Co., Ltd (SHA: 688076) has received marketing approval from China’s National Medical Products Administration (NMPA) for its generic version of Organon’s (NYSE: OGN) Liptruzet (ezetimibe, atorvastatin), becoming the first such product approved in China. The drug, used to treat hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH), was…
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NMPA Approves Sinocelltech’s Finotonlimab for Head and Neck Cancer
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The National Medical Products Administration (NMPA) of China has approved Sinocelltech Group Ltd’s (SHA: 688520) finotonlimab, a programmed-death 1 (PD-1) monoclonal antibody (mAb), for use in combination with platinum-based chemotherapy as a first-line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Sunshine Lake Pharma’s Antaitasvir…
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Nuance Pharma’s Ohtuvayre Receives Regulatory Approval in Macau for COPD Treatment
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China-based Nuance Pharma announced that it has received regulatory approval in Macau for its Ohtuvayre (ensifentrine) as a maintenance treatment for chronic obstructive pulmonary disease (COPD). This approval marks a significant milestone in the company’s efforts to expand the availability of Ohtuvayre in the Greater China region. Innovative Dual-Inhibitor TherapyEnsifentrine…
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Sichuan Kelun-Biotech’s Datailai Gains NMPA Approval for Colorectal Cancer Treatment
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its pipeline candidate A140, a biosimilar version of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab (trade name: Erbitux). The drug, to be traded under the name Datailai, is approved…
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Keymed Biosciences’ Kangyueda Gains NMPA Approval for Seasonal Allergic Rhinitis
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China-based Keymed Biosciences Inc. (HKG: 2162) announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its Kangyueda (stapokibart), an anti-IL-4Rα monoclonal antibody (mAb), this time for its use in seasonal allergic rhinitis. Stapokibart previously gained NMPA approval for the treatment of severe atopic…
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AbbVie’s Emblaveo Wins FDA Approval for Complicated Intra-Abdominal Infections
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US-based pharmaceutical giant AbbVie (NYSE: ABBV) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Emblaveo (aztreonam and avibactam). The drug is the first and only fixed-dose, intravenous, monobactam/β-lactamase inhibitor combination antibiotic approved for use in combination with metronidazole for patients 18…
