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【EXPERT Q&A】How does the FDA of the United States classify medical devices?

Drugdu.com expert’s response: The U.S. Food and Drug Administration (FDA) classifies medical devices into three categories—Class I (low-risk), Class II (medium-risk), and Class III (high-risk)—based on their risk levels, and implements differentiated regulatory requirements for each category. Below is a detailed explanation of the classification logic and regulatory framework: I. Classification Basis: Risk Level and Regulatory Control The FDA’s classification system is grounded in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Medical Device Amendments (MDA), with the core principle that higher risk warrants stricter regulation. Specific classification criteria are as follows: Class I (Low-Risk) Risk Characteristics: Non-invasive, non-life-supporting, with minimal potential harm to the human body. Regulatory Requirements: Implementation of General Controls, including prohibiting the sale of non-compliant products, reporting adverse events, and restricting sales scope. Approximately 93% of Class I devices are exempt from 510(k) submissions, requiring only Enterprise Registration and Product Listing. A minority of Class I devices (e.g., medical gloves, surgical ...
- Source: drugdu
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- December 12, 2025
U.S. ERs Are Failing Sickle Cell Patients In Pain, Study Says

By Dennis Thompson HealthDay ReporterWEDNESDAY, Dec. 10, 2025 (HealthDay News) — U.S. emergency rooms are failing patients in severe pain from a sickle cell disease crisis, a new study says. Only 1 in 3 patients in an ER for sickle cell crisis receive opioid painkillers within the first hour as treatment guidelines recommend, researchers reported Saturday in Orlando at an American Society of Hematology meeting. Adults, in particular, wound up experiencing prolonged suffering while waiting to receive opioids as recommended, researchers found. “One of the challenges of identifying sickle cell disease pain is that there is no biomarker for it, and as a provider, you rely on what the patient tells you about how severe the pain is,” lead researcher Dr. Ibrahim Gwarzo said in a news release. “Providers are more likely to be hesitant to administer opioids for the adult population than for little kids,” said Gwarzo, a research ...
- Source: drugdu
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- December 11, 2025
GLP-1 Medications Show Little Effect on Cancer, Study Shows

WEDNESDAY, Dec. 10, 2025 (HealthDay News) — A new study suggests popular GLP-1 drugs, like Ozempic and Zepbound, may not lower cancer risk as some had hoped. Researchers analyzed 48 randomized trials including 94,245 adults who were overweight, obese or had type 2 diabetes. More than 51,000 people took a GLP-1 drug, and nearly 43,000 received a placebo and were followed for about 70 weeks. The team wanted to know whether these medications change someone’s risk of developing any of the 13 cancers linked to obesity. The results showed GLP-1 drugs had little to no effect on the risk of cancers such as breast, thyroid, pancreatic or kidney cancer. “It’s not that GLP-1 does not reduce the risk of cancer; I don’t think we can make that conclusion from our study,” study co-author Dr. Cho-Han Chiang, a medical oncology fellow at Northwell Health Cancer Institute, told NBC News. “I would ...
- Source: drugdu
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- December 11, 2025
Qilu Pharmaceutical wins blockbuster new drug

Recently, Qilu Pharmaceutical’s pertumumab N01 injection (QL1203) was approved for marketing, for use in combination with FOLFOX as first-line treatment for patients with RAS wild-type (KRAS and NRAS are both wild-type) metastatic colorectal cancer (mCRC) , under the brand name Ankeze. This drug is classified as a Class 3.4 new drug. The original panitumumab (trade name Vectibix) is a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), developed by Takeda in collaboration with Amgen, and has not yet been approved for marketing in China. Epidermal growth factor receptor (EGFR) is currently the most representative targeted therapy target for colorectal cancer treatment. In colorectal cancer, EGFR is often overexpressed, and its high expression is closely related to poor prognosis. EGFR activation can inhibit apoptosis, promote invasion and angiogenesis, ultimately leading to tumor growth. Panitumab has a high affinity for the extracellular portion of the EFGR protein and can competitively bind ...
- Source: drugdu
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- December 11, 2025
Originating from traditional Chinese medicine, it defeated dapagliflozin head-to-head

The field of diabetes drugs is undoubtedly dominated by peptide molecules, but recently an oral small molecule diabetes pipeline drug inspired by traditional Chinese medicine has shown great promise in a head-to-head trial against MNC’s blockbuster drug dapagliflozin. 01 Head-to-head 3-round success Recently, Junshengtai Pharmaceutical ‘s Phase 3 diabetes pipeline asset, HTD1801, has yielded remarkable results in three Phase 3 clinical trials. The latest published result is from the HARMONY trial, a randomized, double-blind, actively controlled Phase 3 study conducted in China. It enrolled 369 adult patients with type 2 diabetes whose condition was not adequately controlled by metformin, comparing HTD1801 with AstraZeneca’s SGLT2 inhibitor dapagliflozin in terms of HbA1c changes at 24 weeks, with a non-inferiority margin set at 0.4%. The results showed that, while maintaining a stable metformin dose, the mean least squares HbA1c level at week 24 decreased by 1.12% from baseline in the HTD1801 group and ...
- Source: drugdu
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- December 11, 2025
Tencent invests in RNA innovative drug R&D company Hongxin Bio

Shenzhen Hongxin Biotechnology Co., Ltd. recently underwent industrial and commercial registration changes, adding Guangxi Tencent Venture Capital Co., Ltd. and others as shareholders, while its registered capital increased to 2.55739 million yuan. Qichacha information shows that the company was established in 2021, and its business scope includes: biomass energy technology services; medical research and experimental development; cell technology research and application, etc. According to its official website, Hongxin Biotechnology is an RNA innovative drug company.Research and development company. https://finance.eastmoney.com/a/202512113588542497.html
- Source: drugdu
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- December 11, 2025
Juncell Therapeutics Submits Hong Kong Listing Application, with CITIC Securities as Sole Sponsor

Juncell Therapeutics has submitted a listing application to the Hong Kong Stock Exchange, with CITIC Securities acting as its exclusive sponsor. Juncell Therapeutics is a biotechnology company dedicated to developing innovative cell therapies and novel drugs for solid tumors, focusing on creating immune cell therapies that are safer, more effective, more accessible, and more affordable. The company’s core product, GC101, is the world’s first tumor-infiltrating lymphocyte (TIL) therapy that does not require high-intensity lymphodepleting chemotherapy or IL-2 administration. It is expected to become the first TIL therapy approved for marketing in China. As a single-dose treatment, TIL cell therapy has the potential to deliver curative outcomes for certain patients with advanced tumors. Clinical data show that TIL therapy also provides long-term benefits to patients with various types of solid tumors, including advanced melanoma, non-small cell lung cancer (NSCLC), and breast cancer. In Phase I clinical trials for advanced metastatic solid ...
- Source: drugdu
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- December 11, 2025
Investee Subsidiary Enters Licensing Agreement with Pfizer for Innovative Metabolic Drug, with Total Potential Value up to $350 Million

Shanghai Securities News, China Securities Network – Chongqing Pharmaceutical Holdings announced on the evening of December 10 that its investee subsidiary, Chongqing Yaoyou Pharmaceutical Co., Ltd. (referred to as “Yaoyou Pharmaceutical”), together with Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., signed a Collaboration and License Agreement (referred to as the “License Agreement”) with Pfizer on December 9. Under the agreement, Yaoyou Pharmaceutical grants Pfizer exclusive rights for the development, use, production, and commercialization of oral small-molecule glucagon-like peptide-1 receptor (GLP-1R) agonists (including YP05002) and products containing this active ingredient within the licensed territory (i.e., globally) and field (covering treatment, diagnosis, and prevention for all human and animal indications). For this license, Yaoyou Pharmaceutical is entitled to receive a non-refundable upfront payment of $150 million and up to $350 million in development milestone payments based on the clinical and commercial progress of the licensed product. It is reported that YP05002 is ...
- Source: drugdu
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- December 11, 2025
We have obtained approval for a Phase I/II clinical trial of JS207 and JS212 for combined use

On December 10, TopAlliance Biosciences, in answering an investor question on an interactive platform, stated that the company has obtained approval for a Phase I/II clinical trial of combined use of JS207 (PD-1/VEGF bispecific antibody) and JS212 (EGFR/HER3 bispecific ADC), and plans to launch related clinical studies in the near future. JS207 is currently in the Phase II clinical study stage. Combination explorations are underway in multiple tumor types, combining JS207 with various drugs such as chemotherapy, monoclonal antibodies, and ADCs. The company will actively explore a variety of combination regimens to maximize the synergistic effect of its pipeline. It is noted that due to the early-stage research and development of pharmaceutical products and the lengthy, multi-stage cycle from R&D and clinical trial application to production, they are susceptible to various uncertainties. https://finance.eastmoney.com/a/202512103587875995.html
- Source: drugdu
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- December 11, 2025
Expedite the review and approval of urgently needed new drugs, rare disease drugs, and pediatric medicines from overseas

Li Li, Secretary of the Party Leadership Group and Director of the National Medical Products Administration (NMPA), stated in an interview that pharmaceutical regulation work is closely related to people’s livelihoods. During the 15th Five-Year Plan period, pharmaceutical regulation will consistently regard enhancing the public’s sense of gain, happiness, and security as its fundamental starting point and ultimate goal. The aim is to ensure that the achievements of reform and development benefit the entire population more extensively and fairly, and to continuously meet the people’s aspirations for a better life and their needs for health protection. The NMPA will make full use of accelerated pathways, such as breakthrough therapy designation, conditional approval, priority review and approval, and special approval procedures. This will expedite the review and approval of urgently needed overseas new drugs, rare disease drugs, and pediatric medicines, shortening the distance from laboratory to bedside and allowing innovative achievements ...
- Source: drugdu
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- December 11, 2025

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