DelveInsight
Apr 30, 2025
Navigating U.S. Tariffs in 2025: Impacts and Strategies for Pharma and Healthcare
In 2025, the United States launched a bold new wave of tariffs, targeting imports critical to the pharmaceutical and healthcare industries. These policies, driven by a push to strengthen domestic manufacturing, impose a 10% tariff on all imported goods, alongside steeper levies of up to 245% on Chinese active pharm...
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Apr 29, 2025
Boston Scientific Pushes Forward Despite $200M Tariff Challenge; Northstrive Biosciences Gets FDA Green Light to Advance EL-22 Obesity Trial; Roche Acts Swiftly to Offset U.S. Tariff Impact with Global Engagements; Verastem Oncology Secures IND Clearance for KRAS G12D Inhibitor Trial; BlackfinBio Gets FDA OK for Phase I/II Trial of BFB-101 in SPG47
Boston Scientific Pushes Forward Despite $200M Tariff Challenge Boston Scientific has announced that tariffs are expected to add approximately $200 million to its costs this year, but the company remains confident in its ability to absorb the financial hit. Despite the tariff burden, the company reported robust ...
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Apr 23, 2025
Exploring the Impact of AI in Mental Health: How it is Going to Revolutionize Diagnosis and Treatment for a Better Tomorrow?
One in every eight people worldwide lives with a psychiatric disorder—a staggering statistic that underscores the deep and growing impact of mental illness on global health. The mental health crisis has evolved into a pressing public health emergency, fueled by increasing social pressures, lifestyle changes, enviro...
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Apr 16, 2025
Non-Surgical Body Contouring: What’s Fueling Its Growth in Aesthetic Medicine?
In the ever-evolving world of aesthetic medicine, non-surgical body contouring has emerged as a beacon of innovation, offering patients a path to their ideal physique without the scalpel. Imagine a treatment that melts away stubborn fat, tightens skin, and even tones muscle—all while you relax, with no downtime to ...
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Apr 15, 2025
Cellenkos’ CK0801 Granted FDA Orphan Drug Status for Aplastic Anemia; Mirum’s LIVMARLI Gets FDA Nod for Tablet Formulation; SynOx’s Emactuzumab Earns FDA Fast Track for TGCT; Bristol Myers Squibb’s OPDIVO + YERVOY Combo Approved by FDA for First-Line Advanced Liver Cancer; Soleno Launches VYKAT XR, the First FDA-Approved Therapy for PWS-Related Hyperphagia
Cellenkos’ CK0801 Granted FDA Orphan Drug Designation for Aplastic Anemia Cellenkos® Inc. announced that the FDA has granted Orphan Drug Designation to CK0801, its off-the-shelf, allogeneic T regulatory (Treg) cell therapy, for the treatment of Aplastic Anemia—a rare and life-threatening bone marrow failure diso...
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Apr 08, 2025
Amgen’s UPLIZNA Wins First FDA Nod for IgG4-Related Disease; Aldeyra Gets FDA CRL for Reproxalap in Dry Eye; Novartis’ Vanrafia Snags Accelerated FDA OK for IgAN Proteinuria; Biogen’s BIIB080 Earns Fast Track for Alzheimer’s; Epicrispr’s EPI-321 Cleared by FDA for FSHD
Amgen’s UPLIZNA Becomes First FDA-Approved Treatment for IgG4-Related Disease Amgen announced that the FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a rare and chronic immune-mediated inflammatory condition that can affec...
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Apr 02, 2025
Revolutionary Advances and Bright New Horizons in Multiple Myeloma Treatment
Multiple myeloma, a complex blood cancer rooted in the bone marrow, affects 160K people globally each year, with a mortality rate of 106K. According to DelveInsight, nearly 75K new cases were reported across seven major markets in 2023, a figure expected to climb in the coming years. Yet, amid these sobering statis...
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Apr 01, 2025
Sanofi’s Qfitlia Becomes First FDA-Approved Therapy for Hemophilia A or B; FDA Approves AstraZeneca’s IMFINZI as First Perioperative Immunotherapy for Bladder Cancer; Beam Therapeutics’ BEAM-302 for AATD Receives FDA Clearance; AstraZeneca’s CALQUENCE Combo Greenlit in EU for Mantle Cell Lymphoma; Ionis’ WAINZUA Wins EU Approval for Hereditary Transthyretin Amyloidosis
Sanofi’s Qfitlia Becomes First US-Approved Therapy for Hemophilia A or B The FDA has approved Qfitlia (fitusiran), the first antithrombin-lowering therapy for routine prophylaxis to prevent or reduce bleeding episodes in hemophilia A or hemophilia B patients (ages 12+) with or without inhibitors. Approval is bas...
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Mar 25, 2025
Clover’s SCB-1019 RSV Revaccination Study Clears U.S. IND; FDA Approves AMVUTTRA for ATTR-CM CV Risk Reduction; Pembrolizumab Combo Greenlit for HER2+ Gastric/GEJ Cancer; TREMFYA Becomes First IL-23 Inhibitor Approved for Crohn’s; FDA OKs GOZELLIX for Prostate Cancer Imaging
Clover’s RSV Vaccine Candidate SCB-1019 Gains U.S. IND Clearance for Revaccination Study Clover Biopharmaceuticals, Ltd. has received FDA clearance for its Investigational New Drug (IND) application and has initiated a Phase I revaccination clinical trial for SCB-1019, its non-adjuvanted bivalent RSV prefusion-s...
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Mar 18, 2025
FDA Expands SOLIRIS for Pediatric Myasthenia Gravis; vTv’s Cadisegliatin Program Resumes as FDA Lifts Hold; ENCell’s EN001 Wins Orphan Drug Designation for Charcot-Marie-Tooth; FDA Accepts Sydnexis’ NDA for SYD-101 in Pediatric Myopia; Cambium Bio’s Potency Assay Strategy Cleared for Elate Ocular Phase III Trials
MDA Applauds FDA’s Expanded Approval of Soliris for Pediatric Generalized Myasthenia Gravis The Muscular Dystrophy Association (MDA) celebrates the FDA approval of an expanded indication for Alexion/AstraZeneca’s eculizumab (Soliris), now authorized for pediatric patients aged six and older with generalized myas...
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