FDA
May 21, 2025
Unveiling Lysosomal Storage Disorders: Exploring Rare Diseases Impacting Millions Worldwide
Lysosomal Storage Disorders, or LSDs, are rare genetic conditions that may not make headlines, but they affect thousands worldwide, often with life-changing consequences. LSDs happen when the body’s lysosomes, tiny cellular recycling centers, fail to break down waste materials due to missing or faulty enzymes. This...
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May 20, 2025
Incyte’s ZYNYZ Approved as First-Line Treatment for Advanced Anal Cancer; Amneal Gets FDA Nod for BREKIYA for Migraines; FDA Accepts Travere’s sNDA for FILSPARI in FSGS; AbbVie’s EMRELIS Approved for Advanced NSCLC With High c-Met; Merck’s WELIREG Approved for Advanced PPGL in Patients 12+
Incyte’s ZYNYZ Approved by FDA as First-Line Treatment for Advanced Anal Cancer The FDA approved ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor developed by Incyte, for the treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC). The approval incl...
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May 13, 2025
Eli Lilly’s ZEPBOUND Surpasses WEGOVY in SURMOUNT-5 Trial; Verastem Oncology Secures FDA Approval for AVMAPKI + FAKZYNJA in KRAS-Mutant Ovarian Cancer; Thermosome Gains Orphan Drug Designation for THE001; Beam Therapeutics Receives RMAT Status for BEAM-302 in AATD; Capsida Biotherapeutics Gets IND Clearance for STXBP1 Gene Therapy
Eli Lilly’s ZEPBOUND Outperforms WEGOVY in SURMOUNT-5 Trial Eli Lilly and Company released detailed results from the Phase IIIb SURMOUNT-5 clinical trial, showing that ZEPBOUND (tirzepatide) significantly outperformed WEGOVY (semaglutide) in weight loss among adults with obesity or overweight and at least one we...
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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 22, 2025
FDA Approves Sanofi/Regeneron’s DUPIXENT as First New CSU Therapy in Over a Decade; Gilead’s TRODELVY + KEYTRUDA Shows PFS Benefit in PD-L1+ TNBC; Tempest’s TPST-1495 Gets FDA Orphan Tag for FAP; uniQure’s AMT-130 Granted FDA Breakthrough for Huntington’s; NeuroNOS’ BA-102 Secures FDA Orphan Status for Phelan-McDermid Syndrome
FDA Approves Sanofi/Regeneron’s DUPIXENT as First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria Regeneron Pharmaceuticals and Sanofi have announced that the FDA has approved DUPIXENT (dupilumab) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous...
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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 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 26, 2025
The Latest Breakthroughs in Obesity Treatment: A New Era of Weight Loss Innovation
Obesity is a chronic disease reaching alarming levels worldwide, leading to diabetes, cardiovascular disease, and metabolic disorders. It results from a mix of genetic, environmental, and lifestyle factors. Understanding what are the reasons for obesity—poor diet, inactivity, and hormonal imbalances—is crucial. Key...
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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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