FDA
Sep 24, 2024
Zevra’s MIPLYFFA Niemann-Pick Disease Approval; FASENRA Approved for Eosinophilic Granulomatosis; Sanofi’s SARCLISA Gets Multiple Myeloma Approval; RYBREVANT Combo Gets FDA Nod for EGFR Lung Cancer; UCB’s BIMZELX Receives Multiple Approval from the FDA
FDA Greenlights Zevra Therapeutics’ MIPLYFFA for Niemann-Pick Disease Type C Zevra Therapeutics, Inc. has announced that the FDA has approved MIPLYFFA (arimoclomol) capsules as the first oral treatment for Niemann-Pick disease type C. Indicated for use alongside miglustat, MIPLYFFA is intended for both adult and...
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Sep 19, 2024
Boston Scientific INGEVITY™ gets Expanded Indication and acquires Silk Road Medical; FDA Approves Philips’ LumiGuide Guidewire; Microbot Completes LIBERTY Trial Enrollment; Innovent Presents Data at ESMO 2024; Argon Medical Launches CLEANER Vac™ System
Boston Scientific Received FDA Approval For The Expanded Indication of INGEVITY™+ Pacing Leads, Allowing For Conduction System Pacing in The Left Bundle Branch Area On September 17, 2024, Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval to expand the indication for th...
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Sep 12, 2024
SpectraWAVE raised $50M; Rockwell Medical signed dialysis deal; Modular Medical got FDA nod for Modd1 pump; iRhythm’s Zio approved in Japan; Autonomix trial showed 83% pain reduction; Insulin Efsitora Alfa improved A1C.
Modular Medical Announced the FDA Clearance for the Modd1 Insulin Pump On September 5, 2024, Modular Medical, Inc., an insulin delivery system technology company, announced that it received the U.S. Food and Drug Administration (FDA) clearance to market and sell its MODD1 pump in the United States. With it...
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Sep 10, 2024
Biogen’s SPINRAZA Phase II/III Trial Results; Travere’s FILSPARI FDA Approval; GSK’s NUCALA Succeeds in COPD Trial; Summit’s NSCLC Win Over KEYTRUDA Raises Caution; FDA Lifts Hold on RZ358 for Congenital Hyperinsulinism
Biogen's Higher SPINRAZA Dose Shows Improved Efficacy in Phase II/III Trial A trial studying a higher dose of Biogen’s spinal muscular atrophy drug SPINRAZA (nusinersen) has met the primary endpoint in a cohort of infants with SMA. The Phase II/III DEVOTE study, which included 145 patients across various ages an...
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Sep 03, 2024
Bayer Phase III NSCLC Trial; D&D Pharmatech Gets FDA Nod for GLP-1R Agonist in Multiple Scletosis; Merck Halts Two KEYTRUDA Trials; Novartis Expands LEQVIO After Phase III Success; Alnylam Reports Strong Phase III Data for Vutrisiran
Bayer Starts Phase III Trial In Non-Small Cell Lung Cancer (NSCLC) Bayer has officially enrolled the first patient in the global Phase III SOHO-02 trial, which will evaluate the efficacy and safety of BAY 2927088 as a first-line treatment for advanced non-small cell lung cancer (NSCLC) with activating HER2 mutat...
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Aug 27, 2024
Merck’s WINREVAIR™ EU Approval; BALVERSA for Urothelial Carcinoma; Novartis and Versant’s Borealis Launched; Moderna’s RSV mRESVIA® EU Approval; FDA Nods RYBREVANT® and LAZCLUZE™ for EGFR-mutated Lung Cancer
Merck’s WINREVAIR Approved by the European Commission for PAH in Adults with Functional Class II-III Merck has secured European Commission (EC) approval for WINREVAIR™ (sotatercept), marking it as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH) approved across all 27 EU me...
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Aug 20, 2024
Gilead’s Livdelzi FDA Approval for Primary Biliary Cholangitis; Incyte and Syndax’s Niktimvo Approved for Graft-Versus-Host Disease; FDA Lifts Hold on BioNTech and MediLink’s ADC Cancer Trial; FDA Approves IMFINZI for Resectable Lung Cancer; Yutrepia Receives Tentative Approval for PAH and PH-ILD
Gilead’s Livdelzi (Seladelpar) Granted Accelerated Approval for Primary Biliary Cholangitis by FDA Gilead Sciences, Inc. has received accelerated approval from the FDA for Livdelzi® (seladelpar) in the treatment of primary biliary cholangitis (PBC). Livdelzi can be used in combination with ursodeoxycholic acid (...
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Aug 13, 2024
FDA Approves Ascendis Pharma’s YORVIPATH; ARS Pharma Gets FDA Green Light for First Nasal Spray; FDA Rejects Lykos’ MDMA-Assisted PTSD Therapy; Novartis’ FABHALTA Receives FDA Accelerated Approval; Servier Snags FDA Approval for Voranigo
Ascendis Pharma Lands Long-Awaited FDA Drug Approval in Rare Hormone Deficiency Ascendis Pharma A/S has announced that the FDA has approved YORVIPATH (palopegteriparatide; developed as TransCon PTH) for the treatment of hypoparathyroidism in adults. YORVIPATH, a prodrug of parathyroid hormone (PTH[1-34]), is adm...
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Aug 08, 2024
MIMEDX Launches HELIOGENTM Fibrillar Collagen Matrix; DocGo Launches Mobile X-ray Program; Labcrop’s FDA De Novo Marketing Authorization; Inspire Medical Systems Receives FDA Approval; Alcyone Therapeutics Announces Continued Enrollment Approval from the FDA; Lunit’s AI for Tuberculosis Detection
MIMEDX Announced the Launch of HELIOGENTM Fibrillar Collagen Matrix On July 31, 2024, MiMedx Group, Inc. launched HELIOGEN™ Fibrillar Collagen Matrix, a particulate xenograft product designed to treat complex wounds, especially in surgical environments. HELIOGEN is a shelf-stable product that contains Type...
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Aug 06, 2024
Tecelra by Adaptimmune: First FDA-Approved Engineered Cell Therapy for Solid Tumors; GSK’s JEMPERLI Approved for Endometrial Cancer; MBX Biosciences Secures $63.5M in Series C for PEP™ Platform; FDA Stops Actinium’s Radiotherapy Blood Cancer Plans, Pushing Partnering Shift; Otsuka Acquires Jnana for Up to $1.1B, Enhancing Drug Discovery
Adaptimmune’s TECELRA Becomes First FDA-Approved Engineered Cell Therapy for Solid Tumors Adaptimmune Therapeutics announced that the FDA has approved (afamitresgene autoleucel), which will be marketed under the brand name TECELRA, for the treatment of unresectable or metastatic synovial sarcoma. This marks the ...
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