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Sino Medical Sciences Receives Hong Kong Approval for HT Supreme Drug-Eluting Stent System
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Sino Medical Sciences Technology Inc., (SHA: 688108), a Chinese medical technology company, has announced that it has received marketing approval in Hong Kong for its HT Supreme drug-eluting stent system. The system is now approved for use in symptomatic heart disease patients to improve the coronary artery lumen diameter caused…
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Hainan Poly Pharm Secures Tentative FDA Approval for Generic Version of UCB’s Briviact
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received tentative marketing approval from the US Food and Drug Administration (FDA) for its generic version of Belgium-based UCB’s Briviact (brivaracetam). Briviact is recognized as a selective high-affinity synaptic vesicle protein 2A (SV2A) ligand,…
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J&J’s Rybrevant Secures Full FDA Approval for NSCLC with EGFR Exon 20 Insertions
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The US Food and Drug Administration (FDA) has granted Johnson & Johnson (J&J; NYSE: JNJ) full approval for the use of Rybrevant (amivantamab) in combination with chemotherapy for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. This bispecific antibody (BsAb)…
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CARsgen Therapeutics’ BCMA-targeted CAR-T Cell Therapy Approved by China’s NMPA
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CARsgen Therapeutics Holdings Ltd (HKG: 2171), a specialist in chimeric antigen receptor (CAR)-T cell therapies based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product CT053 (zevorcabtagene autoleucel; zevor-cel). This B-cell maturation antigen (BCMA)-targeted CAR-T cell therapy is now…
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Gilead’s Biktarvy Receives FDA Approval for Expanded HIV Treatment Indication
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Gilead (NASDAQ: GILD), a leading US pharmaceutical company, has been granted an indication extension approval for its antiretroviral combination Biktarvy (bictegravir + emtricitabine + tenofovir alafenamide) by the Food and Drug Administration (FDA). The approval expands Biktarvy’s use as an HIV treatment for individuals who have suppressed viral loads and…
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Alvotech Scores FDA Nod for Interchangeable High-Concentration Biosimilar to Humira
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The US Food and Drug Administration (FDA) has granted approval to Iceland-based Alvotech’s (NASDAQ: ALVO) Simlandi, marking it as the first interchangeable high-concentration, citrate-free biosimilar to AbbVie’s (NYSE: ABBV) immunosuppressant Humira (adalimumab). Humira faced patent expiration in the US last year, leading to biosimilar competition. Simlandi is approved for various…
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Takeda’s Recombinant Pig FVIII Drug for Acquired Hemophilia A Approved in China
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The National Medical Products Administration (NMPA) website has indicated that Takeda (TYO: 4502)’s Obizur (susoctocog alfa), intended for on-demand treatment and control of bleeding events in adult patients with acquired hemophilia A, has received approval in China. This drug marks the first recombinant pig FVIII (rpFVIII) to be approved by…
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Rossum Robot’s Intelligent Surgical Robot for Trauma and Spinal Surgery Clears NMPA Approval
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Rossum Robot, a Beijing-based developer of orthopedic surgical robots specializing in pelvic fracture procedures, has received marketing approval from the National Medical Products Administration (NMPA) for its intelligent small surgical robot designed for trauma and spinal surgery applications. This regulatory clearance marks a significant advancement for Rossum Robot as it…
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AstraZeneca’s Tagrisso Meets PFS Endpoint in Late-Stage NSCLC Trial and Expands FDA Approval
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AstraZeneca (AZ; NASDAQ: AZN), a leading UK-based pharmaceutical company, has announced that a late-stage trial for Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI), has successfully met its primary endpoint of progression-free survival (PFS) in patients with unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC). The trial evaluated a once-daily…
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Pfizer’s Velsipity Approved by European Commission for Moderately to Severely Active Ulcerative Colitis
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The European Commission (EC) has granted regulatory approval to Pfizer (NYSE: PFE) for its S1P receptor modulator Velsipity (etrasimod) as a treatment for patients aged 16 and older with moderately to severely active ulcerative colitis (UC). The approval applies to patients who have had an inadequate response, lost response, or…
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FDA Authorizes Biweekly Dosing for J&J’s Tecvayli in Multiple Myeloma Treatment
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The US Food and Drug Administration (FDA) has granted authorization for a biweekly dosing regimen of Johnson & Johnson’s (J&J; NYSE: JNJ) bispecific T-cell engager (BiTE) Tecvayli (teclistamab). Tecvayli received accelerated approval in 2022 for the treatment of relapsed or refractory multiple myeloma (r/rMM) in patients who have undergone at…
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Innovent Biologics’ Tyvyt Receives Marketing Approval for Multiple Indications in Macau
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Innovent Biologics Inc., (HKG: 1801), a leading biopharmaceutical company based in China, has announced that it has received marketing approval for Tyvyt (sintilimab injection), a PD-1 inhibitor co-developed with US pharmaceutical giant Eli Lilly, for multiple indications in Macau. The drug has been approved to treat classic Hodgkin’s lymphoma (cHL),…
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Zylox-Tonbridge Receives UAE Approval for Five Medical Devices, Expands Middle East Presence
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Zylox-Tonbridge (HKG: 2190), a Chinese specialist in medical devices, has announced a series of product marketing approvals from the United Arab Emirates (UAE) Ministry of Health and Prevention. The company received approval for a total of five products, including the ZENFluxion Drug-coated PTA Balloon Catheter, ZENFlow HP PTA Balloon Catheter,…
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WuXi ATU’s Philadelphia Facility Approved for Amtagvi Production Following FDA Nod
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WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec (SHA: 603259, HKG: 2359) based in China, has announced the U.S. FDA’s approval of its Philadelphia facility to commence analytical testing and manufacturing of Amtagvi (lifileucel) for Iovance. This novel therapy received accelerated approval for its Biologics License…
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Hainan Poly Pharm Wins FDA Nod for Generic Version of UCB’s Vimpat
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Hainan Poly Pharm Co., Ltd (SHE: 300630), a Chinese pharmaceutical company, has announced that it has received marketing approval from the US Food and Drug Administration for its generic version of UCB’s Vimpat (lacosamide), originally developed by the Belgium-headquartered UCB. The approved generic will be used for the treatment of…
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FDA Approves Takeda’s Eohilia as First Oral Therapy for Eosinophilic Esophagitis in Patients Aged 11 and Up
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The U.S. Food and Drug Administration (FDA) has granted approval to Takeda Pharmaceutical Company (TYO: 4502)’s Eohilia (budesonide oral suspension) for the treatment of eosinophilic esophagitis (EoE). This marks Eohilia as the first and currently only oral therapy available for EoE patients aged 11 and older. Previously, Novartis (NYSE: NVS)’s…
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Roche’s Piasky (Crovalimab) Secures NMPA Approval for Untreated Paroxysmal Nocturnal Hemoglobinuria
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The National Medical Products Administration (NMPA) has granted marketing approval to Swiss pharmaceutical giant Roche (SWX: ROG) for Piasky (crovalimab) under priority review status. This approval is specifically for the treatment of adult and adolescent patients aged 12 and older with paroxysmal nocturnal hemoglobinuria who have not previously received treatment…
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MSD’s Keytruda Secures 13th Indication Approval in China for Biliary Carcinoma Treatment
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Merck, Sharp & Dohme (MSD; NYSE: MRK), a leading US pharmaceutical company, has announced that its drug Keytruda (pembrolizumab) has received approval from the National Medical Products Administration (NMPA) in China for a new indication. The drug is now approved as a first-line treatment for locally advanced or metastatic biliary…
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Peijia Medical’s Taurus Atlas Pro Balloon Dilation Catheter Approved by NMPA for Pulmonary Valve Procedures
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Peijia Medical Ltd (HKG: 9996) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its second-generation balloon dilation catheter, Taurus Atlas Pro. This non-compliant balloon is designed for percutaneous transluminal valvuloplasty of the pulmonary valve. The Taurus Atlas Pro balloon dilation catheter is…
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MicroPort CRM Receives NMPA Approval for Next-Generation MRI-Safe Implantable Cardiac Pacing System
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MicroPort Scientific Corp. (HKG: 0853), a leading Shanghai-based medical device company, has announced that its France-based subsidiary MicroPort Cardiac Rhythm Management Limited (MicroPort CRM) has received a market license from the National Medical Products Administration (NMPA) for its next-generation intravenous magnetic resonance conditionally safe implantable cardiac pacing system. The product…
