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Merck and Eisai’s Welireg Plus Lenvima Approved by FDA for Previously Treated Advanced Kidney Cancer

On September 25, Merck (MSD) and Eisai announced FDA approval of Welireg® (belzutifan), an oral HIF-2α inhibitor, in combination with Lenvima® (lenvatinib), for adults with advanced renal cell carcinoma (ccRCC) with a clear cell component previously treated with a PD-1 or PD-L1 inhibitor. The approval is based on the LITESPARK-005 Phase 3 study, which showed the Welireg+Lenvima combination reduced the risk of disease progression or death by 30% versus cabozantinib. This provides a new all-oral option for patients after immunotherapy failure. Source: https://www.merck.com/news/welireg-belzutifan-plus-lenvima-lenvatinib-reduced-the-risk-of-disease-progression-or-death-by-30-compared-to-cabozantinib-in-certain-previously-treated-patients-with-advanced-renal-ce/
- Source: drugdu
- 172
- September 29, 2026
Mirum and Incyte’s Atebrioz Wins FDA Approval for Rare Bone Disorder FOP

On September 25, Mirum Pharmaceuticals and Incyte announced that the U.S. FDA approved Atebrioz™ (zilurgisertib) to reduce new heterotopic ossification (HO) volume in patients aged 12 and older with fibrodysplasia ossificans progressiva (FOP). Zilurgisertib is a once-daily oral small-molecule inhibitor of activin receptor-like kinase 2 (ALK2), directly blocking the key signaling pathway driving abnormal bone formation in soft tissue. FOP is an ultra-rare progressive genetic disorder in which soft tissue gradually ossifies, causing severe mobility impairment. The approval was based on the pivotal Phase 2 PROGRESS study. Mirum licensed worldwide rights from Incyte. Source: https://ir.mirumpharma.com/news/news-details/2026/Mirum-Pharmaceuticals-and-Incyte-Announce-U-S–FDA-Approval-of-Atebrioz-zilurgisertib-for-Adult-and-Pediatric-Patients-with-Fibrodysplasia-Ossificans-Progressiva/default.aspx
- Source: drugdu
- 170
- September 29, 2026
J&J in Talks to Sell DePuy Synthes to Apollo

Johnson & Johnson is in talks to sell its orthopedics business DePuy Synthes to private equity firm Apollo Global Management for approximately $20 billion. DePuy Synthes was formed from J&J’s 1998 ($3.5B) and 2012 ($21.3B) acquisitions of DePuy and Synthes, covering joint reconstruction, sports medicine, trauma, and the Velys orthopedic surgical robot.DePuy Synthes generated $9.258B in 2025, growing only 1.1% vs. 6.1% for J&J’s broader MedTech segment. Stryker overtook it as global #1 in orthopedics with ~$11.4B. Chinese centralized procurement also pressures the business. H1 2026 sales were $4.801B (+5.6%), showing recovery. J&J has not officially announced the deal; a spin-off remains an option. Source: https://news.yaozh.com/archive/49060.html
- Source: drugdu
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- September 29, 2026
APAC Leadership Transition and Cyberattack Hits Full-Year Guidance

Boston Scientific announced that Arthur Butcher, EVP and Head of International MedSurg, will retire. Butcher joined in 1996, served as EVP & President of Asia Pacific from 2020-2022, and has led MedSurg & APAC Group since 2022 after over 30 years with the company. He will step down on January 1, 2027. Boston Scientific has also been recovering from a major cyberattack identified on August 25, 2026 that disrupted global operations. On September 8, the company stated the incident could materially impact Q3 and full-year results, and it expects to miss prior net sales growth and adjusted EPS guidance. This follows a July 29 guidance cut to 5%-6% organic growth due to slowing electrophysiology and Watchman momentum. Source: https://news.yaozh.com/archive/49062.html
- Source: drugdu
- 131
- September 29, 2026
Huadong Medicine Discloses Positive Top-line Results for Weight-loss Drug, Pipeline May Be Revalued

Huadong Medicine announced that its wholly-owned subsidiary Sino-American East China has achieved positive top-line results in the China Phase III trial (HDM1002-301) of its Class 1 innovative oral small-molecule GLP-1 receptor agonist HDM1002 tablets for weight management in overweight or obese individuals. All dosage groups met all primary and key secondary endpoints at week 44; continued treatment resulted in sustained weight loss further decreasing at week 52 without a plateau; significant improvements in cardiometabolic markers, substantial reduction in liver fat content, and optimized body composition were observed; safety and tolerability were consistent with the GLP-1 class with no new signals. The company has completed Pre-NDA communication and will soon submit a marketing application in China. Research institutions indicate the biopharmaceutical industry will benefit from upcoming policies, with related companies expected to see improved performance. Source: https://finance.eastmoney.com/a/202609283885024341.html
- Source: drugdu
- 107
- September 29, 2026
Core Product Velyso Granted Orphan Drug Designation in Japan

On September 28, Leads Biolabs-B (09887) announced that its core product Velyso® (opatidijumimab, a PD-L1/4-1BB bispecific antibody) has been granted orphan drug designation by the Japanese Ministry of Health, Labour and Welfare for the treatment of extrapulmonary neuroendocrine carcinoma (EP-NEC). This is the third orphan drug designation that Velyso® has received, following those from the U.S. Food and Drug Administration and the European Commission, marking a further expansion of its global regulatory recognition into major Asian markets. Source: https://finance.eastmoney.com/a/202609283885132814.html
- Source: drugdu
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- September 29, 2026
Healthcare Facilities Symposium & Expo

、 Organiser： Austin International Medical Association Time：September 28-30, 2026 Address：501 S College St, Charlotte, NC 28202, USA Exhibition hall：CHARLOTTE CONVENTION CENTER Product range: ‌Medical Equipment‌: Medical equipment, electronic medical instruments, dental equipment ‌Testing, Analysis & Diagnostic Instruments‌: Testing, analysis and diagnostic instruments, monitoring instruments ‌Medical Consumables‌: Consumables, disposable products, cotton and linen medical textiles ‌Medical Furniture‌: Medical furniture ‌Assistive Products‌: Assistive products for people with disabilities ‌Nursing & Rehabilitation Equipment‌: Nursing and rehabilitation instruments ‌Cleaning, Disinfection & Sterilization Products‌: Cleaning, disinfection and sterilization products ‌Pharmaceuticals & Nutritional Health Products‌: Pharmaceuticals and nutritional health products ‌Medical Packaging‌: Medical packaging About Healthcare Facilities Symposium & Expo： Healthcare Facilities Symposium & Expo is one of the most important medical device exhibitions in the United States. It aims to create a multidisciplinary environment that inspires change through physical spaces and promotes better healthcare delivery. The previous edition of the Healthcare Facilities Symposium & ...
- Source: drugdu
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- September 29, 2026
【EXPERT Q&A】The buyer said that the sample test has passed. How can the project be pushed to a trial order next?

Drugdu.com expert’s response: In pharmaceutical foreign trade, after sending out samples, the sentence that every salesperson most looks forward to seeing is probably: “Sample passed our test.” However, upon receiving this message, some sales representatives do not know how to follow up properly. They simply reply: “Great, looking forward to your order.” And then start waiting. Several days pass with no order from the client; a week later, they send another message: “Any update?” The client replies: “We are still discussing internally.” Gradually, the entire project grinds to a halt. A sample passing the test is certainly good news, but there is usually a noticeable gap between “qualified sample” and “formal procurement”. At this stage, what suppliers need to confirm is no longer whether the product is usable, but how the client plans to make the purchase. Confirm the purchase quantity and timeline right after sample approval The sample phase is meant to ...
- Source: drugdu
- 89
- September 28, 2026
【EXPERT Q&A】When a buyer makes an inquiry and only leaves the product name and country, which questions should be asked in the first round?

Drugdu.com expert’s response: In pharmaceutical foreign trade, it is very common to receive extremely short inquiries. For example: “Need Vitamin D3, Pakistan.” or “Looking for disposable syringe, UAE.” Sometimes buyers only leave the product name, country and email address, with no other information provided. There are no specifications, no quantity, no intended use, and no explanation of whether they are importers, distributors or end purchasers. Such inquiries cannot be directly judged as invalid. Some buyers are just testing whether the supplier will respond, some are sourcing goods for their end clients, and some have not sorted out their complete requirements yet. The focus of your first reply is not to quote immediately, nor to send all product catalogs and certificates at once. Instead, you should first ask for several most critical pieces of information. Confirm the specific specification or model first The product name alone provided by the buyer is ...
- Source: drugdu
- 98
- September 25, 2026
ExpoMedical, the Argentina Medical Devices, Hospital Supplies and Laboratory Equipment Exhibition

Organiser：ExpoMedical Time：September 23-25, 2026 Address：Av. Costanera R. Obligado and J. Salguero, Buenos Aires, Argentina Exhibition hall：Costa Salguero Exhibition Center Product range: Medical Equipment‌: Medical devices, electronic medical equipment, diagnostic instruments and equipment for all clinical departments, testing instruments, medical optical instruments, X-ray equipment, imaging equipment, scanning equipment, nuclear magnetic resonance, ultrasonic diagnosis, clinical laboratory analytical instruments, hemodialysis equipment, dental equipment, anesthesia and respiratory equipment, interventional diagnosis, dialysis equipment. ‌Medical Supplies‌: Disposable medical supplies, consumables, syringes, blood transfusion sets, sanitary cotton, adhesive bandages, masks, bandages, stethoscopes, medical ambulances, operating room supplies, work uniforms, medical kits, gloves, various types of medical scalpels, forceps, scissors, small electronic instruments, testing equipment, orthopedic technology, medical beds, surgical supplies, disinfection supplies, cleaning technology, ambulance service supplies, wound dressings. ‌First Aid Supplies‌: First aid equipment, emergency equipment, pharmaceutical products, drugs, infusions, disinfectants, blood derivatives, nutritional products, dermatological drugs, veterinary drugs, bandages, medical dressings, surgical ...
- Source: drugdu
- 108
- September 24, 2026

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