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The first in nearly 20 years! The FDA has approved the marketing of this innovative drug

Recently, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Denali Therapeutics’ innovative drug Avlayah (tividenofusp alfa) for the treatment of Hunter syndrome (Mucopolysaccharidosis II). This approval marks a dual breakthrough: it is not only the first new treatment option for this disease in nearly 20 years but also the first FDA-approved enzyme replacement therapy that utilizes a transferrin receptor-mediated mechanism to cross the blood-brain barrier. Hunter syndrome is a rare genetic lysosomal storage disorder caused by a deficiency of the enzyme iduronate-2-sulfatase (IDS), leading to abnormal accumulation of glycosaminoglycans throughout the body’s cells, with particularly severe damage to the central nervous system. While traditional enzyme replacement therapies can improve peripheral symptoms, they cannot effectively cross the blood-brain barrier and therefore fail to halt neurological decline. The key innovation of Avlayah lies in its TransportVehicle™ (TV) platform technology. This engineered technology enables the drug to bind to transferrin ...
- Source: drugdu
- 95
- March 31, 2026
The Guangzhou International Exhibition on Laboratory Medicine, In Vitro Diagnostics, and Blood Transfusion Instruments and Reagents (IVDE)

Organiser：China Association for Medical Devices Industry Time：March 30 – April 1, 2026 Address：Intersection of Yingbin Avenue and Fanghua Road, Baiyun District, Guangzhou Exhibition hall：Guangzhou Airport Expo Center Product range: In Vitro Diagnostic Equipment Category: Biochemical analyzers, bacterial analyzers, urine analyzers, microbiological analyzers, electrolyte analyzers, hematology analyzers, blood analyzers, hemodialysis machines, enzyme-linked immunosorbent assay (ELISA) readers, chromatographs, PCR instruments, etc. In Vitro Diagnostic Reagent Category: In vitro diagnostic reagents, rapid diagnostic reagents, electrolyte reagents, hematology reagents, blood coagulation reagents, blood typing reagent kits, lipid reagents, biochemical reagents, chemiluminescent reagents, dry chemistry test strips, reagents for chlamydia detection, protein detection reagents, infectious disease detection reagents, tumor marker reagents, human gene detection reagents, immunohistochemistry and human tissue cell reagents, biochips, vitamin determination reagents, cellular and tissue chemical staining agents, self-diagnostic reagents, microbiological testing reagents, and other diagnostic reagents. Blood Collection and Transfusion Category: Blood collection and supply instruments and equipment, consumables, blood ...
- Source: drugdu
- 107
- March 31, 2026
Say goodbye to lifelong IV drips! FDA approves first in vivo gene therapy for infantile Pompe disease

Abstract: Rocket Pharma announced that its in vivo gene therapy Kresladi (libmeldagene autotelcel) has recently received FDA approval for the treatment of infantile Pompe disease (IOPD) . This is the world’s first one-time gene therapy for this disease, delivering a functional GAA gene to repair the defect at its source, overcoming the limitation of traditional enzyme replacement therapy requiring lifelong treatment, and bringing new hope for survival to severely affected children. I. FDA Approval Finally Granted! Kresladi Opens a New Chapter in Pompe Disease Treatment Let’s look at the key news first: Rocket Pharma’s Kresladi has received FDA approval, becoming the first approved one-time gene therapy for infantile Pompe disease . This drug uses an adeno-associated virus (AAV) vector to target and deliver the drug to the patient’s liver, where it continuously expresses the functional GAA enzyme. I’ve been following the clinical progress of this drug for over two years, ...
- Source: drugdu
- 80
- March 30, 2026
The National Medical Products Administration has approved the marketing of Demozia maca injection

Recently, the National Medical Products Administration (NMPA) approved the marketing of Demozia macaase injection (trade name: Easily) submitted by GlaxoSmithKline Trading Services Limited. This product is indicated for maintenance treatment of severe eosinophilic asthma in adults and adolescents aged 12 years and older. The approval of this product provides a new treatment option for these patients. Source: Official WeChat account of the National Medical Products Administration https://mp.weixin.qq.com/s/_3PsNe601R7lhzvh1cSn2w
- Source: drugdu
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- March 30, 2026
Recombinant type A botulinum toxin for injection successfully approved for marketing

On the evening of March 27, Huadong Medicine announced that its exclusively distributed product, recombinant botulinum toxin type A for injection (trade name: Retoxin®), has been approved for marketing by the National Medical Products Administration for the temporary improvement of moderate to severe frown lines caused by the activity of the corrugator supercilii and/or depressor supercilii muscles in adults aged 65 and under. The announcement shows that Retoxin® was independently developed by Chongqing Yuyan Pharmaceutical and owns global intellectual property rights. Huadong Medicine owns the exclusive commercialization rights of this product in the field of medical aesthetic indications in mainland China, Hong Kong and Macau, as well as related priority acquisition rights and priority negotiation rights. In addition, the company holds 4.2787% of the equity of Chongqing Yuyan Pharmaceutical Co., Ltd. through its wholly-owned subsidiary Xinkeli Aesthetics (Hangzhou) Medical Technology Co., Ltd. According to Frost & Sullivan data, the Chinese ...
- Source: drugdu
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- March 30, 2026
providing new options for patients with psoriasis and hidradenitis suppurativa.

On March 27 , 2026 , Zhejiang Bioray Bio-Pharmaceutical Co., Ltd. (hereinafter referred to as “Bioray Bio-Pharmaceutical”) and UCB, a global biopharmaceutical company, jointly announced that their biologic * (trade name: Bejule® ) , was approved by the National Medical Products Administration ( NMPA ) of China on the same day for the treatment of adult patients with moderate to severe plaque psoriasis who are suitable for systemic therapy or phototherapy , and for the treatment of adult patients with moderate to severe hidradenitis suppurativa (acne paradoxica) who have not responded well to conventional systemic therapy . This approval marks the official expansion of this first-line IL-17A/F dual-target biologic agent , the world’s first and currently the only one approved in China, from the field of rheumatology and immunology to the field of dermatology, bringing new treatment options to millions of patients in China suffering from these two chronic, relapsing, ...
- Source: drugdu
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- March 30, 2026
GE Healthcare’s Photon-Counting CT System Approved by FDA

Recently, GE Healthcare announced that its photon-counting CT system, Photonova Spectra, has received 510(k) marketing clearance from the U.S. Food and Drug Administration. It is understood that this product features wide-area coverage and ultra-high-resolution spatial and spectral imaging capabilities, enabling rapid acquisition and precise display of subtle tissue differences, small lesions, and vascular structures. Moreover, equipped with its self-developed deep silicon detector technology, it builds a flexible photon-counting CT platform that can meet diverse clinical needs through various configurations. Its deep silicon technology offers 8-energy-level spectral resolution, supporting advanced material separation and characterization capabilities, allowing Photonova Spectra to accurately distinguish between different substances such as iodine, calcium, and fat. The wide-area detector coverage combined with a fast rotation speed of 0.23 seconds ensures high-speed acquisition and motion-artifact-free imaging. Furthermore, Photonova Spectra can automatically and simultaneously acquire 8-energy-level spectral data and ultra-high-resolution spatial data without requiring special settings or scanning protocols, ...
- Source: drugdu
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- March 30, 2026
350 Million Yuan! Diabetes Pulse Therapy Startup Completes Another Round of Financing

Recently, according to foreign media reports, Endogenex completed a $50 million (approximately 350 million yuan) Series C extension financing. This funding will be used to complete the development of its type 2 diabetes electrical pulse therapy and submit the technology to the U.S. Food and Drug Administration (FDA) for approval. Endogenex was founded in 2017 and focuses on the diabetes field. Its promising product—the ReCET system—targets the upper small intestine, specifically the duodenal region, aiming to reset inflammation and dysfunctional tissues associated with type 2 diabetes and improve the intestine’s ability to regulate blood sugar, appetite, and digestion. According to Endogenex, the ReCET system can deliver pulsed electric fields to the inner mucosal layer of the organ through an endoscopic electrode array, thereby clearing dysfunctional cells and stimulating tissue regeneration while avoiding potential thermal damage. This technology has previously received FDA breakthrough device designation. It is reported that shortly before ...
- Source: drugdu
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- March 30, 2026
【EXPERT Q&A】How to carry out clinical evaluation of medical devices?

Drugdu.com expert’s response: Conducting clinical evaluation of medical devices is a critical step to ensure their safety, efficacy, and compliance with regulatory requirements. It must be carried out in accordance with regulations such as the Regulations on the Supervision and Administration of Medical Devices and the Technical Guidelines for Clinical Evaluation of Medical Devices, while selecting an appropriate pathway and implementing it systematically based on the characteristics of the product. Here are the specific steps and key points: I. Clarify the Clinical Evaluation Pathway Select one of the following three pathways based on the risk level and maturity of the medical device: 1. Products Listed in the Catalog Exempt from Clinical Evaluation Applicability: Low-risk products with mature technologies (e.g., some Class I and Class II devices). Requirements: Confirm that the product is fully consistent with the description in the catalog, including structural composition, performance, and intended use. Submission: Submit a declaration without additional ...
- Source: drugdu
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- March 30, 2026
【EXPERT Q&A】What are the reasons for the increase in the prices of innovative drugs?

Drugdu.com expert’s response: The reasons for the rise in innovative drugs are mainly as follows: Policy Support Establishment of a Systematic Support System: The “Full-Chain Support Plan for the Development of Innovative Drugs” introduced in 2024 has constructed a systematic support system for the innovative drug industry, covering the entire process from R&D to commercialization. It highlights the synergistic effects of the three core areas: pricing mechanisms, medical insurance payments, and commercial insurance, ensuring that innovative drug companies can make profits from selling drugs, accelerating the speed at which innovative drugs are included in medical insurance lists, and shortening the post-launch market ramp-up period. Advancement of Priority Review and Approval Policies: For instance, on May 29, 2025, 11 innovative drugs (including 7 Class 1 innovative drugs) were approved in a single day, setting a new high for the same period in the past five years and underscoring the direct boost ...
- Source: drugdu
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- March 27, 2026

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