All Blogs
Sep 26, 2023
LEQEMBI Intravenous Infusion Approval; Novartis’ Presented Updates on Lutathera; FDA Accepts Submission to Add PH-ILD to YUTREPIA Label; FDA Issues CRL to BLA for Pegfilgrastim-cbqv; FDA Fast Track Designation to Therpay, MWTX-003; EC Approves TEPKINLY (epcoritamab) for R/R DLBCL
Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera On Sept. 20, 2023, Disc Medicine, Inc. (NASDAQ: IRON) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with Polycyt...
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Sep 25, 2023
Orchard’s OTL-200 to Enter US Metachromatic Leukodystrophy Treatment Space After EU
Orchard Therapeutics’ Biologics License Application for OTL-200, a gene therapy under investigation for metachromatic leukodystrophy treatment, has been accepted by the FDA. This rare disease treatment received approval in Europe back in 2020. Notably, the FDA has granted Orchard’s application Priority Review statu...
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Sep 22, 2023
Myelofibrosis Treatment Market Heats Up with GSK’s Momelotinib Entry
On September 15, the FDA authorized GSK’s oral medication momelotinib, now known as Ojjaara, for the treatment of myelofibrosis in adults with anemia. Myelofibrosis is a disorder where normal bone marrow tissue is slowly substituted by fibrous, scar-like material. It is categorized as a form of chronic leukemia and...
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Sep 21, 2023
Zepp Health Launched OTC Hearing Aids; Neoss Launched NeoScan 2000; FDA Clearance for AI-Assisted Sleep Monitoring Device Dreem 3S; Tasso Received CE Mark Certification for Tasso+; Neuralink’s First-in-human BCI trial; Creative Medical to Initiate a Phase I/II Clinical Trial of StemSpine
Zepp Health Launched a New Line of OTC Hearing Aids for its Zepp Clarity Brand On September 19, 2023, Zepp Clarity, a smart hearing solutions brand owned by Zepp Health, a health technology company, announced the launch of Zepp Clarity Pixie, a next-generation premium hearing solution. The Pixie, which ...
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Sep 20, 2023
Sleep Aids Market: Examining Cutting-Edge Technologies and Major Breakthroughs
Sleep Aids Market: Examining Cutting-Edge Technologies and Scientific Breakthroughs Sleep can be burdensome when it disrupts daily routines, requires a significant time commitment, and is marred by sleep disorders or disturbances that affect overall well-being. In today's fast-paced world, where stress, anxiety,...
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Sep 19, 2023
FDA Approves Ojjaara for Myelofibrosis; EMA Grants PRIME Designation to Iopofosine I-131; EBGLYSS Receives Positive CHMP Opinion; FDA Accepts Resmetirom NDA; FDA Fast Track Designation to KT-333 for PTCL; RedHill Announces FDA sNDA Approval for Talicia®
EBGLYSS Receives Positive CHMP Opinion for Moderate-to-Severe Atopic Dermatitis Almirall S.A. announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the marketing authorization of EBGLYSS (lebrikizumab) for the treatment o...
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Sep 18, 2023
A Turning Point: INGREZZA’s Impact on Huntington’s Disease Treatment and the Rise of Novel Therapies
Huntington’s disease is an incurable, rare genetic, progressive neurodegenerative disorder. According to the National Organization for Rare Disorders (NORD), about 30,000 people in the United States have Huntington’s disease, and another 200,000 are at risk of developing the condition. As per DelveInsight analy...
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Sep 15, 2023
Myelodysplastic Syndrome Treatment Market: Unveiling the Robust Pipeline
The number of people diagnosed with myelodysplastic syndrome in the US each year is unknown. However, some estimates have put this number at about 10,000, while other estimates have been much higher. Moreover, myelodysplastic syndrome is uncommon before age 50, and the risk increases as a person gets older. It is a...
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Sep 14, 2023
Mindray’s 2-in-1 Handheld Ultrasound Device; NuVasive’s Precice Bone Transport System; FDA for alveofit’s alveoair; FDA 510(k) Clearance Limaca’s Precision GI™ Endoscopic Biopsy Device; Evolution Optiks’s Neuro-Optical Testing Device; Moderna Expanded Field of mRNA Medicine
Mindray Launched Groundbreaking 2-in-1 Handheld Ultrasound Device with Multi-device Connectivity On September 7, 2023, Mindray, a global leader and developer of healthcare solutions and technologies in ultrasound, patient monitoring, and anesthesia announced the release of its new imaging solution, the TE ...
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Sep 13, 2023
Biosurgery: Advancing Medicine through Biologically Derived Solutions
In recent years, the healthcare and medical devices market has undergone a remarkable transformation, largely fueled by advancements in technology and growth in innovation. One of the major standout developments in the healthcare industry is the rise of the biosurgery market and the related product demand, whic...
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