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Yifan Pharmaceutical’s F-627 Approved by European Commission for Marketing in EU
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Yifan Pharmaceutical Co., Ltd (SHE: 002019), a Chinese pharmaceutical company, has announced that its subsidiary Evive Biotech Ltd’s drug Ryzneuta (efbemalenograstim alfa, F-627) has received marketing approval from the European Commission (EC) in the European Union (EU), following a recommendation by the European Medicines Agency’s Committee for Medicinal Products for…
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FDA Grants Accelerated Approval for Takeda’s Iclusig in Newly Diagnosed Ph+ ALL
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The U.S. Food and Drug Administration (FDA) has granted accelerated indication extension approval to Japan’s Takeda Pharmaceutical Company (TYO: 4502) for its tyrosine kinase inhibitor (TKI) Iclusig (ponatinib) in combination with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). This follows the drug’s previous…
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Everest Medicines’ Nefegan Approved by Singapore HSA for Primary IgAN Treatment
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Everest Medicines (HKG: 1952), a China-based biotechnology company, has received marketing approval from the Singapore Health Sciences Authority (HSA) for its drug Nefegan, also known as Nefecon, which is indicated for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. Nefecon is…
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Sino Medical Sciences Secures South Korean Approvals for Three Cardiovascular Devices
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Sino Medical Sciences Technology Inc., (SHA: 688108), a leading Chinese medical device company, has announced that it has received marketing approvals from South Korean regulatory authorities for three of its cardiovascular products: the HT Supreme drug-eluting stent, the NC ROCKSTAR non-compliant balloon dilation catheter, and the SC HONKYTONK coronary balloon…
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BeiGene’s Tislelizumab Receives FDA Approval for Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that the US Food and Drug Administration (FDA) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The approval is for patients who have been previously treated…
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Bristol Myers Squibb’s Breyanzi Receives FDA Accelerated Approval for CLL/SLL Treatment
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The US Food and Drug Administration (FDA) has granted accelerated approval to Bristol Myers Squibb’s (BMS; NYSE: BMY) CAR-T cell therapy Breyanzi (lisocabtagene maraleucel) for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults who have undergone at least two prior lines…
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KeChow Pharma Secures Conditional Approval for HL-085, a First-of-Its-Kind MEK Inhibitor for Advanced Melanoma
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Shanghai-based KeChow Pharma has received conditional marketing approval from the National Medical Products Administration (NMPA) for its Category 1 drug HL-085, aimed at treating advanced melanoma with NRAS mutations in patients who have experienced failure with anti-PD-1/PD-L1 therapies. HL-085 is a groundbreaking ATP non-competitive MEK inhibitor that specifically targets NRAS…
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Pfizer’s Sugemalimab Secures NMPA Approval for Gastric and Gastroesophageal Junction Adenocarcinoma
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Pfizer (NYSE: PFE), a leading pharmaceutical company in the US, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for sugemalimab, a programmed death-ligand 1 (PD-L1) inhibitor, for the first-line treatment of inoperable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma (G/GEJ) expressing…
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Madrigal Pharmaceuticals’ Rezdiffra Earns FDA Accelerated Approval for NASH in Adults
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The US Food and Drug Administration (FDA) has granted an accelerated approval to Madrigal Pharmaceuticals’ (NASDAQ: MDGL) Rezdiffra (resmetirom) for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) in adults with moderate-to-advanced liver fibrosis. This marks the first approval in the US for a therapy indicated for liver scarring due to…
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European Commission Approves Pfizer’s Prevenar 20 for Pediatric Use
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its 20-valent pneumococcal vaccine, Prevenar 20, aimed at preventing invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in individuals aged 6 weeks to 18 years. This vaccine was previously approved for use in adults…
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ClouDr Launches Dapagliflozin, Generic Version of AstraZeneca’s Forxiga, After NMPA Approval
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Hangzhou Kang Ming Information Technology Co., Ltd. (HKG: 9955), known as “ClouDr,” has officially launched dapagliflozin, its self-operated product with marketing rights. This drug serves as a generic version of AstraZeneca (NASDAQ: AZN)’s Forxiga, a leading treatment for type 2 diabetes. The approval for dapagliflozin was secured through Nanjing F&S…
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FDA Approves Wegovy for Cardiovascular Risk Reduction in Obese Patients, First of Its Kind
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The U.S. Food and Drug Administration (FDA) granted an indication extension approval last week to Novo Nordisk (NYSE: NVO) for its GLP-1 receptor agonist Wegovy (semaglutide), allowing it to be used for the reduction of major adverse cardiovascular events (MACE) in overweight or obese adults with established cardiovascular disease (CVD).…
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BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
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China Grand Pharmaceutical Receives FDA Approval for Post-Surgical Ophthalmic Drug GPN00833
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China Grand Pharmaceutical and Healthcare Holdings Ltd (HKG: 0512; CGP) has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its hormone nanosuspension eye drops GPN00833 (APP13007), designed for anti-inflammatory and analgesic effects following ophthalmic surgery. Additionally, the company has gained clinical trial…
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Boehringer Ingelheim’s Spevigo Receives NMPA Approval for GPP Treatment in China
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German pharmaceutical giant Boehringer Ingelheim (BI) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its biologic drug Spevigo (spesolimab) subcutaneous injection. The drug is indicated for reducing the incidence of generalized pustular psoriasis (GPP) in adolescents aged 12 and above weighing at…
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Henlius Biotech’s HER2 Targeting Biosimilar Secures Thai and Philippine Approvals
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Shanghai Henlius Biotech Inc., (HKG: 2696) a leading China-based biotech firm, has announced that its biosimilar version of Roche’s Herceptin, known as Hanquyou (trastuzumab; HLX02), has been granted marketing authorization in both Thailand and the Philippines. The drug, which is marketed under the trade names TRAZHER and Hertumab in these…
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Sino Medical Sciences Gains Pakistani Nod for SC HONKYTONK and NC ROCKSTAR Catheters
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Sino Medical Sciences Technology Inc., (SHA: 688108) a Chinese medical device company, has announced that it has received marketing approvals in Pakistan for two of its cardiovascular products: the SC HONKYTONK coronary balloon dilation catheter and the NC ROCKSTAR non-compliant balloon dilation catheter. These approvals mark a further expansion into…
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Formosa Pharmaceuticals Secures FDA Nod for New Steroidal Eye Drug, Set to Launch via Eyenovia
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Taiwan-based Formosa Pharmaceuticals (TPE: 6838) has received approval from the US Food and Drug Administration (FDA) for its new formulation of the steroidal eye drug clobetasol propionate (0.05%), designed to treat post-operative inflammation and pain following ocular surgery. The drug will be commercialized in the US by Eyenovia Inc., (Nasdaq:…
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Sandoz Achieves FDA Milestone with Approval of First US Denosumab Biosimilars
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The US Food and Drug Administration (FDA) has granted Sandoz (SWX: SDZ), a Switzerland-based pharmaceutical company, registration approvals for its biosimilars Wyost (denosumab) and Jubbonti (denosumab). These biosimilars reference and share the same indications as Amgen’s (NASDAQ: AMGN) bone treatments Xgeva and Prolia, respectively. With this approval, Sandoz’s drugs become…
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Pfizer’s Cibinqo Secures NMPA Approval for Expanded Use in Atopic Dermatitis
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The National Medical Products Administration (NMPA) has released drug approval certificate delivery information that points to a new indication approval for Pfizer (NYSE: PFE)’s JAK1 inhibitor Cibinqo (abrocitinib), a small molecule targeted therapy. This approval expands the drug’s use to include the treatment of moderate to severe atopic dermatitis (AD)…
