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FDA Elevates Dubai Chocolate Spread Recall to Class 1 Over Salmonella Risk

By Denise Mann HealthDay ReporterMONDAY, July 21, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) has escalated the recall of a popular Dubai chocolate spread sold nationwide to its highest alert level due to salmonella risks. So far, four cases of salmonella and one hospitalization have been linked to the outbreak, according to the CDC. World Market initiated the voluntary recall of a batch of Emek Gıda’s pistachio-cocoa spread on July 14, after samples tested positive for salmonella contamination. Three days later, the recall was updated to a Class 1 alert. The Class 1 designation signifies a “reasonable probability” that consuming the spread could cause serious illness or death, according to the FDA. Salmonella can cause serious and potentially fatal infections in young children, the frail or elderly, and others with weakened immune systems, the FDA warned. Symptoms of Salmonella infection in healthy individuals may include fever, ...
- Source: drugdu
- 154
- July 23, 2025
WuXi Biologics’ Five Manufacturing Sites Pass U.S. FDA Pre-approval Inspections; First Commercial Prefilled Syringe Filling Plant Approved

On July 21, WuXi Biologics announced that its five manufacturing sites successfully passed the U.S. Food and Drug Administration (FDA) pre-approval inspection (PLI) with zero critical findings and zero data integrity issues. The nine-day FDA inspection covered WuXi Biologics ‘ quality management system and the entire production process of its two bulk drug manufacturing plants (MFG1 and MFG5) and three drug product manufacturing plants (DP1, DP2, and DP5) in Wuxi, China. As the company’s first commercial prefilled syringe (PFS) filling plant, DP5 passed the regulatory inspection for the first time, laying a solid foundation for it to provide high-quality prefilled syringe production solutions to global customers. https://finance.eastmoney.com/a/202507213462123078.html
- Source: drugdu
- 104
- July 23, 2025
Clinical trial of innovative drug for rosacea treatment of Taienkang has been accepted

On the evening of July 18, TaienkangAn announcement was released stating that the application for a Phase II/III seamless adaptive clinical trial for the rosacea indication of CKBA cream developed by the company’s holding subsidiary, Bo Chuang Park, had recently received an acceptance notice issued by the National Medical Products Administration. The announcement shows that rosacea is a chronic, recurrent inflammatory skin disease that occurs most frequently in women aged 20 to 50, with symptoms such as facial flushing, erythema, papules, pustules and telangiectasia. So far, there is no Class 1 innovative drug for the treatment of rosacea in China.Approved for marketing. According to Taienkang , the company’s CKBA cream is a major achievement of more than 20 years of basic research by Wang Honglin’s team at Shanghai Jiaotong University. It is the world’s first innovative small molecule drug targeting the T cell fatty acid metabolism pathway (by inhibiting the ...
- Source: drugdu
- 93
- July 23, 2025
Taking effect in 30 minutes, the domestically produced new ED drug Onvida® has been approved. Is the multi-billion dollar market about to undergo a change?

Recently, the official website of the State Food and Drug Administration announced that the Class 1 new drug Selenafil Hydrochloride Tablets (trade name: Onvida®) applied by Suzhou Wangshan Wangshui Biotechnology was officially approved for marketing for the treatment of male erectile dysfunction (ED). The research and development of Onvida® began ten years ago. Founded in 2013, Wangshan Wangshui Biopharmaceuticals, as the first biopharmaceutical company incubated by the Suzhou Achievement Transformation Center of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences, set its sights on the ED treatment market, which was then monopolized by multinational pharmaceutical companies. The research team drew inspiration from flavonoid natural products, and after a large number of screening and structural optimization, they finally obtained a highly active and highly selective phosphodiesterase 5 (PDE5) inhibitor with independent intellectual property rights. In March 2016, the drug obtained a clinical trial approval; in February 2023, it completed ...
- Source: drugdu
- 1,246
- July 23, 2025
Giants increase investment, and triple antibody becomes a “new outlet”

Recently, AbbVie spent $700 million upfront to introduce IGI Therapeutics SA (IGI)’s new trispecific antibody drug ISB 2001, with exclusive rights to develop, manufacture and commercialize in North America, Europe, Japan and Greater China. According to the agreement, IGI will receive a $700 million upfront payment and is eligible to receive up to $1.225 billion in development, regulatory and commercial milestone payments, as well as tiered double-digit net sales royalties. According to public information, ISB 2001 is a trispecific antibody targeting CD38, BCMA and CD3. It is currently in Phase 1 clinical development for the treatment of relapsed/refractory multiple myeloma and has been granted orphan drug designation and fast track status by the FDA. Currently, a number of dual-antibody drugs targeting BCMA and CD3 have been approved for marketing for multiple myeloma, including Johnson & Johnson’s Tecvayli, Pfizer’s Elrexfio and Regeneron’s Lynozyfic. ISB 2001 adds CD38 to the combination to ...
- Source: drugdu
- 292
- July 23, 2025
【EXPERT Q&A】How should the clinical evaluation path for Class II active medical devices be selected?

Drugdu.com expert’s response: The selection of clinical evaluation pathways for Class II active medical devices should be based on product risk levels, technical characteristics, and data availability, with evaluations completed through three pathways: exemption from clinical trials, comparison with predicate devices, or clinical trials. The specific analysis is as follows: I. Core Pathway Selection Criteria Exemption from Clinical Trials Pathway Applicable Conditions: The product is listed in the Catalogue of Medical Devices Exempt from Clinical Evaluation and fully aligns with the descriptions in the catalogue. Key Operational Points: Submit comparative data between the product and the catalogue entries, along with a comparison statement with legally marketed medical devices already approved in China (covering fundamental principles, structural composition, performance requirements, etc.) to demonstrate equivalence. Typical Examples: Low- to moderate-risk products such as general surgical instruments and certain rehabilitation aids. Comparison with Predicate Devices Pathway Applicable Conditions: The product is essentially equivalent to a legally ...
- Source: drugdu
- 122
- July 23, 2025
FDA Approves New Prefilled Syringe Presentation of GSK’s Shingrix for Shingles Prevention

The FDA has approved a new prefilled syringe presentation of Shingrix, GSK’s recombinant zoster vaccine for the prevention of shingles (herpes zoster). According to the company, the updated format eliminates the need for reconstitution of two separate vials, streamlining administration and reducing complexity for healthcare providers. The approval is based on data showing technical comparability to the current two-vial version.1 How Will the New Shingrix Presentation Benefit Providers and Patients? “The prefilled syringe presentation of GSK’s shingles vaccine is good news, providing a convenient method of administration,” said Brigid Groves, VP, professional affairs, American Pharmacists Association, in a press release. “The FDA approval is a positive step toward driving prevention of this painful disease, and as a practicing pharmacist I welcome the availability of this new presentation.” Same Shingrix Indications, Streamlined Format GSK stated that the new presentation maintains the same indications: for adults aged 50 years and older, ...
- Source: drugdu
- 304
- July 22, 2025
Specially engineered antibody delivers RNA therapy to treatment-resistant tumors

A specially engineered antibody capable of delivering RNA therapies to hard-to-reach, treatment-resistant tumors significantly shrank tumor size and improved survival in animal models, according to a study published July 16 in Science Translational Medicine. The study provides evidence that, once injected into the bloodstream, the antibody TMAB3, combined with a type of RNA that stimulates an innate immune reaction, can localize to tumors and penetrate and destroy stubborn diseased cells in pancreatic, brain, and skin cancers. “Delivery of RNA-based therapies to tumors has been a challenge. Our finding that TMAB3 can form antibody/RNA complexes capable of delivering RNA payloads to tumors provides a new approach to overcome this challenge.” From Peter Glazer, senior author and Robert E. Hunter Professor of Therapeutic Radiology and Genetics at Yale School of Medicine (YSM) In addition to Glazer and Yale first authors Elias Quijano, PhD; Diana Martinez-Saucedo, PhD; Zaira Ianniello, PhD; and Natasha Pinto-Medici, ...
- Source: drugdu
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- July 22, 2025
Phase III clinical trial of Tian Tan Biological’s intravenous injection of human immunoglobulin for new indications

On the evening of July 17th, Tiantan Biotechnology disclosed an announcement on the progress of clinical trials for its subsidiary companies’ drugs. According to the announcement, Chengdu Rongsheng Pharmaceutical Co., Ltd., a subsidiary of the company, has completed clinical ethics review and pre enrollment preparations for the newly added indication of chronic inflammatory demyelinating polyneuropathy in its marketed product “Intravenous human immunoglobulin (pH4)” (10%, 50ml). The Phase III clinical trial has been officially launched recently. This new indication is the first clinical study in China to approve the use of intravenous immunoglobulin products for the indication of chronic inflammatory demyelinating polyneuropathy. The main procedures required for the approval of new indications for the above-mentioned products include completing phase III clinical trials, submitting a new indication permit application, and obtaining approval for new indications after being reviewed by the Drug Evaluation Center of the National Medical Products Administration and approved by ...
- Source: drugdu
- 56
- July 22, 2025
Can probiotics help you sleep better?

In a recent review article published in the journal Frontiers in Microbiology, researchers summarized the current scientific knowledge on the effects of probiotic supplementation on sleep quality and mood in individuals with insomnia. Based on the evidence from randomized controlled trials (RCTs), they concluded that probiotic interventions may significantly improve sleep quality (with moderate certainty) and reduce symptoms of depression (with very low certainty) without increasing the risk of adverse events. However, these results were highly heterogeneous, and the overall strength of evidence varied between outcomes. A high burden of insomnia Insomnia is a widespread sleep disorder characterized by difficulty falling or staying asleep, or experiencing non-restorative sleep, that occurs frequently over at least three months. It can occur on its own (primary insomnia) or due to other conditions (secondary insomnia), though the two are often difficult to distinguish. The disorder is linked to heightened brain activity and physiological imbalances, ...
- Source: drugdu
- 66
- July 22, 2025

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