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The FDA has conditionally approved a drug for the treatment of canine cerebellar tonsillar herniation and syringomyelia.

Pregabalin chewable tablets relieve nerve-related pain by reducing the release of neurotransmitters involved in pain signal transmission within the spinal cord. The U.S. Food and Drug Administration (FDA) has approved pregabalin chewable tablets ( Liavium-CA1 ; TriviumVet ) for the treatment of pain and clinical symptoms associated with canine cerebellar tonsillar herniation (CM) and syringomyelia. This approval was granted to TriviumVet, a company headquartered in Ireland . The FDA ‘s approval pathway is a conditional approval pathway, which is used for drugs intended to treat serious or life-threatening diseases, fill unmet animal health needs, and require complex or particularly difficult studies to demonstrate their effectiveness. Cerebellar tonsillar herniation (CM) is a genetic disorder in dogs where the skull is too small, causing the cerebellum to protrude beyond the base of the skull. This restricts the flow of cerebrospinal fluid and leads to syringomyelia, a condition characterized by painful cavities filled ...
- Source: drugdu
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- May 13, 2026
The U.S. FDA approved Bio-Thera Solutions’ supplemental application for changes to its bevacizumab manufacturing process and facilities

Bio-Thera Solutions, Ltd. (Stock Code: 688177 ) , a global biopharmaceutical company based in Guangzhou, China, is a science-driven innovation enterprise . The Company today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a supplemental application for Avzivi® ( BAT1706 , bevacizumab injection). This approval relates to the Avzivi® manufacturing process , the 4,000 – liter monoclonal antibody solution production line, and the vial formulation production line . This approval will significantly enhance the production capacity of bevacizumab, thereby better meeting the clinical needs of patients worldwide and ensuring a continuous and stable supply of high-quality drugs . Avzivi® is a bevacizumab injection developed by Bio-Thera Solutions in accordance with the relevant guidelines for biosimilars from the NMPA , FDA , and EMA . It is a humanized monoclonal antibody belonging to the vascular endothelial growth factor ( VEGF ) inhibitor class. It ...
- Source: drugdu
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- May 13, 2026
Beilu Pharmaceutical’s Iodofluoxetine Injection Approved

Recently, Beilu Pharmaceutical received the Drug Registration Certificate for Ioflufenicol Injection issued by the National Medical Products Administration . The original manufacturer of Ioflucanol injection is Mallinckrodt in the United States. Its indications are: (1) coronary angiography and left ventricle angiography, aortic angiography, peripheral and visceral artery angiography in adults; (2) enhanced CT scan of the head and body in adults, venography and excretory urography; (3) cardiovascular angiography in children. Ioflufenicol injection has been included in the National Medical Insurance Category A Catalog. According to data from Menet.com, the sales of Ioflufenicol injection in China’s three major terminals and six major markets have been increasing year by year in recent years, exceeding 3 billion yuan in each of the three major terminals and six major markets from 2023 to 2025. It has consistently ranked first among contrast agents (chemical drugs + biological drugs). Ioflufenicol injection has been approved as a ...
- Source: drugdu
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- May 13, 2026
【EXPERT Q&A】How to apply for and obtain the production and operation license for Class III medical devices?

Drugdu.com expert’s response: Class III Medical Device Production License → Apply to the Provincial Drug Administration Class III Medical Device Operation License → Apply to the Municipal Drug Administration Both require compliant premises, qualified personnel, a quality management system, and a traceability system. Statutory approval period: 20 working days. Validity: 5 years. I. Production License (Provincial Drug Administration) 1. Application Requirements Corporate Qualification: Legal corporate entity; business scope must cover the corresponding production category. Premises & Environment: Production facilities and cleanroom environment must match the product standards. Personnel: Production, Quality, and Technical Directors must hold a relevant major, a college degree or above, and at least 3 years of experience. Inspection personnel and equipment must be fully staffed. Equipment & Documentation: Production and inspection equipment must be complete. Quality manual, procedure documents, and process flowcharts must be fully prepared. Product Registration: The Medical Device Registration Certificate must already be obtained. 2. Required Materials Medical Device ...
- Source: drugdu
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- May 13, 2026
CanSino Biologics’ Td5cp for adolescents and adults has been included in the priority review process, accelerating its deployment of DPT protection throughout the entire life cycle.

May 11, 2026 – CanSino Biologics Inc. (hereinafter referred to as “ CanSino Biologics ” , 688185.SH , 06185.HK ) announced that its independently developed adsorbed acellular diphtheria-tetanus-diphtheria-tetanus combined vaccine ( for individuals aged 6 years and older) (hereinafter referred to as “ Td5cp for adolescents and adults ” ) has been officially included in the priority review list by the National Medical Products Administration ( NMPA ). With the accelerated review and approval process, this product, as an important part of the company’s comprehensive DPT protection system throughout the entire life cycle, is expected to fill the gap in DPT booster immunization products for individuals aged 6 years and older in China, helping to build a broader and stronger immune barrier. Pertussis is an acute respiratory infectious disease caused by Bordetella pertussis, and it is highly contagious . <sup> 1 </sup> In recent years, pertussis has shown a resurgence ...
- Source: drugdu
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- May 12, 2026
Industry News | Harbour BioMed Announces FDA Approval of HBM7004 for the Treatment of Advanced Solid Tumors

Harbour BioMed (“the Company”; HKEX code 02142), a global biopharmaceutical company dedicated to the discovery and development of novel antibody therapeutics in the fields of immunology, oncology, and other diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for HBM7004, thereby initiating a first-in-human (FIH) Phase I clinical trial. This study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of HBM7004 in subjects with advanced solid tumors. HBM7004 is a novel B7H4xCD3 bispecific antibody developed using the company’s HBICE® platform . This bispecific antibody is designed to provide a differentiated approach to cancer immunotherapy, potentially improving efficacy and safety. The development of HBM7004 further demonstrates the versatility and plug-and-play advantages of the HBICE® platform . In preclinical studies, HBM7004 exhibited a tumor-dependent B7H4-dependent T-cell activation pathway. In multiple animal models, HBM7004 demonstrated strong antitumor efficacy, significant in vivo stability, ...
- Source: drugdu
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- May 12, 2026
The world’s first! GSK’s blockbuster hepatitis B drug licensed to Chia Tai Tianqing Pharmaceutical Group.

China Biopharmaceutical has acquired the world’s first blockbuster drug with the potential to achieve a functional cure for hepatitis B in the fastest possible time. On May 11, China Biopharmaceutical (01177.HK) officially announced that its core subsidiary, Chia Tai Tianqing Pharmaceutical Group, has entered into an exclusive strategic collaboration with multinational pharmaceutical company GlaxoSmithKline (LSE/NYSE: GSK) to accelerate the latter’s first-in-class innovative drug for chronic hepatitis B , Bepirovirsen (code name: GSK836), in China. This promising drug, which is highly anticipated by the industry, has received “breakthrough therapy” designation in China and has been included in the priority review and approval process. Its launch will bring a revolutionary breakthrough to the treatment of hepatitis B in China. Under the terms of the agreement, Chia Tai Tianqing Pharmaceutical Group will be responsible for the import, distribution, hospital access, and promotional and non-promotional activities of bepirovirsen in mainland China. All sales revenue ...
- Source: drugdu
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- May 12, 2026
The Two Sides of RMC-6236

Following Revolution’s announcement on April 13th of positive results from the Phase III clinical trial RASolute302 of its pan-RAS inhibitor RMC-6236 in previously treated metastatic pancreatic cancer patients, the drug has now announced the latest research progress in first-line treatment. In terms of efficacy, RMC-6236 continues to surprise the market, demonstrating impressive remission rates whether used as a monotherapy or in combination therapy, and bringing new expectations to the industry. However, the potential toxicity of RMC-6236 continues to emerge. In particular, in the RMC-GI-102 study of first-line combination chemotherapy, grade ≥3 adverse reactions accounted for as high as 73%. Currently, the impact of this safety hazard on the subsequent R&D layout of RMC-6236 is still unclear, but it has pointed out a clear direction for differentiated breakthroughs for subsequent competitors in the same field. 01 The Two Sides of RMC-6236 RMC-6236 is a two-sided unit. In terms of efficacy, it ...
- Source: drugdu
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- May 12, 2026
A rare disease company was acquired for $4.1 billion.

Italian pharmaceutical company Angelini Pharma recently announced its acquisition of Catalyst, a US-based rare disease specialist, for $4.1 billion, aiming to capitalize on the lucrative US market. The two companies expect to close the deal in the third quarter. According to publicly available information, Catalyst was founded in 2002 and went public on NASDAQ in 2006. The company is patient-centric, focusing on the introduction, development, and commercialization of novel medicines for rare and intractable diseases. In 2025, Catalyst’s revenue reached $589 million, a 20% increase, and this year’s revenue is projected to be between $615 million and $645 million. It has three products already on the market: Firdapse (amifampridine) is the company’s flagship product. It is the only evidence-based treatment approved by the FDA for Lambert-Eaton myasthenic syndrome (LEMS) in patients aged 6 and older. Sales of this drug are projected to reach $358 million in 2025, a 17% year-on-year ...
- Source: drugdu
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- May 12, 2026
BIO

Organiser：BIO Convention Time：June 22 – June 25, 2026 Address：111 W. Harbor Dr., San Diego, CA 92101 Exhibition hall：San Diego Convention Center Product range: Biotechnology and products, biopharmaceutical R&D achievements, biotechnology parks and industrial base development, applications of biotechnology in healthcare, food, agriculture, energy, environmental protection, as well as international marketing and academic promotion of biotech products, intellectual property protection, clinical research and trials, investment and financing, technology transfer, and more. About BIO： The BIO International Convention (commonly known as BIO) was founded in 1993 and serves as the annual conference of the Biotechnology Innovation Organization (BIO). It is the largest, most professional, and most influential biotechnology event in the world. BIO aims to support the development of the global biotechnology industry. Through sponsoring biotechnology projects and initiatives, the profits from the convention are reinvested back into the biotechnology sector. The event is not primarily trade-oriented; instead, it emphasizes a ...
- Source: drugdu
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- May 12, 2026

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