All Blogs
Jun 23, 2025
How Could the Approval of JOURNAVX Accelerate the Non-opioids Drug Approval Momentum in Post-Operative Care?
Imagine waking up after successful surgery only to experience moderate-to-severe pain (acute or chronic). For decades, the standard of care (SoC) has been the same for postoperative care: prescribe an opioid. While effective in limiting pain signals, opioids have left behind a baggage of addiction and overdose.&nbs...
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Jun 20, 2025
Advancements in IgA Nephropathy (IgAN) Treatment: From Standard-of-care (SoC) to Emerging Therapies
IgA Nephropathy (IgAN): Pathogenesis and the Need for Targeted Therapies IgA nephropathy is a complex autoimmune disorder characterized by the accumulation of galactose-deficient IgA1 antibodies in the glomeruli, triggering a cascade of immune responses that ultimately lead to chronic kidney damage. Driven by a ...
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Jun 19, 2025
Presidio Medical™ Gains IDE Nod for ULF™ Study, Names Dimas Jiménez CFO; Creo Medical Gains FDA Nod for SpydrBlade™ Flex, Paving Way for U.S. Launch; Penumbra Completes Patient Enrollment in Pivotal STORM-PE RCT; Adona Medical Completes Enrollment in First-in-Human Trial of Novel Interatrial Shunt for Heart Failure; Johnson & Johnson Launches TECNIS Odyssey Intraocular Lens in Europe, Middle East, and Canada for Enhanced Cataract Care; Philips Sets New Benchmark in POCUS Technology with Flash 5100 Launch
Presidio Medical™ Received IDE Approval for Ultra Low Frequency (ULF™) Neuromodulation Clinical Study and Appoints Dimas Jiménez as Chief Financial Officer On June 12, 2025, San Mateo, California–Presidio Medical, Inc., a global clinical-stage medical device company, received Investigational New Drug (IDE)...
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Jun 18, 2025
Exploring Life-Saving Heart Devices: Innovations Transforming Cardiac Care
Heart disease continues to be a major global health concern, impacting countless lives and placing a significant burden on healthcare systems worldwide. According to the World Health Organization, cardiovascular diseases are responsible for approximately 17.9 million deaths each year, accounting for nearly one-thir...
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Jun 17, 2025
Celltrion Announces FDA Nod for New STEQEYMA Presentation to Broaden Pediatric Use; CSL’s ANDEMBRY Gets FDA Nod as First Factor XIIa Inhibitor for Hereditary Angioedema; Ocugen’s OCU410ST Cleared by FDA to Begin Phase II/III Trial in Stargardt Disease; Milestone Pharmaceuticals Submits FDA Response for CARDAMYST in PSVT; AbbVie’s MAVYRET Approved by FDA as First and Only Therapy for Acute Hepatitis C
Celltrion Announces FDA Approval of New STEQEYMA Presentation, Expanding Pediatric Dosing Options Celltrion, Inc. has announced that the FDA has approved an additional presentation of STEQEYMA (ustekinumab-stba), a biosimilar to STELARA, in a 45mg/0.5mL single-dose vial for subcutaneous injection. This new formu...
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Jun 16, 2025
IgG4-Related Disease: A Niche Autoimmune Disorder with Expanding Drug Development Interest
IgG4-related disease (IgG4-RD) was first identified as a systemic condition between 2001 and 2003 in a group of Japanese patients. Subsequently, in 2011, Japan’s Ministry of Health, Labor and Welfare introduced the first diagnostic criteria for the disease. Although specific data on the period prevalence of IgG4...
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Jun 13, 2025
Navigating the Loss of Exclusivity: Big Pharma’s New Playbook
The Patent Cliff Returns: Can Big Pharma Innovate Fast Enough to Stay on Top? For decades, blockbuster drugs have fueled the pharmaceutical industry’s golden age. But as the 2020s unfold, a familiar threat is resurfacing with unprecedented intensity: the Loss of Exclusivity (LOE). With patents on multibillion-do...
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Jun 12, 2025
Samsung Galaxy Watch Sleep Apnea Feature Cleared for Europe With CE Certification; ZEISS CLARUS 700 Gains NMPA Approval in China; Envoy Medical’s Acclaim® Cochlear Implant Trial Progresses as Planned Following First Month Follow-Up; Masimo SedLine® Shown to Enhance Brain Monitoring Accuracy in Pediatric Anesthesia; Penumbra Launches Ruby® XL System; Johnson & Johnson Introduces the ETHICON™ 4000 Stapler
Samsung Expands Global Reach of Sleep Apnea Feature on Galaxy Watch With CE Marking Certification in Europe On June 5, 2025, Samsung Electronics Co., Ltd. announced the expanded global availability of its Sleep Apnea feature on the Galaxy Watch series, accessible through the Samsung Health Monitor app. The...
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Jun 11, 2025
AI Healthcare Startups: Unveiling Investment and Funding Trends
Buckle up, because the world of AI healthcare startups is on fire! Investors are throwing serious cash, think billions, at companies using artificial intelligence to shake up the pharmaceutical industry. Over the past decade, a jaw-dropping USD 60 billion has flooded into AI healthcare startups, with USD 30 billion...
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Jun 10, 2025
Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants
Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS Amylyx Pharmaceuticals announced that the FDA has granted Fast Track designation to its investigational antisense oligonucleotide (ASO), AMX0114, for the treatment of amyotrophic lateral sclerosis (ALS). The candidate targets calpain-2...
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