May 15, 2023
On March 29, 2023, the FDA made the landmark decision to approve Emergent BioSolutions’ NARCAN nasal spray for over-the-counter (OTC) and nonprescription use, making it the first naloxone product to be approved for use without a prescription. With about 80,000 fatal opioid overdoses every year, this could potent...
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May 11, 2023
Norlase Received FDA 510(k) Clearance and CE Mark Approval For ECHO™ Green Pattern Laser On May 5, 2023, Norlase, a leading global ophthalmic laser manufacturer developing next-generation laser solutions, received both 510(k) US Food and Drug Administration clearance and CE Mark approval for the ECHO Gree...
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May 12, 2023
By bringing life-changing benefits to people with rare diseases and cancers, cell and gene therapies are reshaping the field of medicine. These treatments have recently gained tremendous publicity for meeting long-standing unmet needs and being extremely costly. But high production costs are limiting patient access...
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Jun 06, 2025
The implementation and adoption of new-age technologies such as augmented and virtual reality in healthcare are driving innovation and shaping the future of the medical field. While AR and VR are not new concepts, the past few years have witnessed tremendous advances, powered by improvements in camera and sensor te...
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May 09, 2023
FDA Approves GSK’s Arexvy, the First RSV Vaccine for Older Adults GSK plc stated that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by a respiratory syncytial virus (RSV) in peopl...
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May 08, 2023
In recent years, the development of cell and gene therapies has provided a new avenue for the treatment of rare disorders. This article will discuss the current and future scenarios of cell and gene therapies in rare disorders with cancer indications as an exception, in Japan. Cell therapy is a treatment in which l...
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May 05, 2023
Infections due to respiratory syncytial virus (RSV) have seriously troubled drug makers for decades and the need for a vaccine was on since the 1960s. According to the assessment done by DelveInsight on the latest published “Respiratory Syncytial Virus Epidemiology Report,” it is estimated to affect approximately 5...
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May 04, 2023
Apyx Medical Corporation Received FDA 510(k) Clearance for the Use of Renuvion® for Coagulation of Subcutaneous Soft Tissues Following Liposuction for Aesthetic Body Contouring On April 28, 2023, Apyx Medical Corporation, the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and ...
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May 03, 2023
Cancer is a global burden, leading to a significant number of death and disabilities worldwide. In 2020, nearly one in six deaths were related to cancer. Breast cancer, lung cancer, colon and rectum cancer, and prostate cancer are some of the major cancer types, registering the highest number of cases globally. To ...
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May 02, 2023
FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...
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