news
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 17, 2024
Johnson & Johnson’s TREMFYA Approved for Ulcerative Colitis; Roche’s Tecentriq Hybreza Approved as Subcutaneous Anti-PD-(L)1; OCREVUS ZUNOVO Receives Twice-a-Year Multiple Sclerosis Injection Approval; Lilly’s EBGLYSS Greenlit for Moderate-to-Severe Atopic Dermatitis; DUPIXENT Approved for Adolescents with Chronic Rhinosinusitis
TREMFYA Approved for Moderately to Severely Active Ulcerative Colitis Johnson & Johnson announced that the FDA has approved TREMFYA (guselkumab) for treating adults with moderately to severely active ulcerative colitis. TREMFYA is the first fully human, dual-acting monoclonal antibody that blocks IL-23 and b...
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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 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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Jul 30, 2024
IMFINZI’s AEGEAN Phase III Trial Data for Treating Resectable NSCLC; Ipsen and Day One’s Exclusive Agreement to License and Market Tovorafenib Outside the US; Alzheimer’s Drug LEQUEMBI Rejected by EU; EU Apporves Pfizer’s Gene Therapy DURVEQTIX; CHMP Approves SPEVIGO’s New Indications
The FDA Advisory Committee Considers the AEGEAN Phase III Trial Data in their Review of IMFINZI for Treating Resectable NSCLC The FDA's Oncologic Drugs Advisory Committee (ODAC) acknowledged that AstraZeneca’s IMFINZI (durvalumab) achieved the primary endpoint of event-free survival (EFS) in resectable non-small...
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Jul 16, 2024
Immutep’ First-Line Treatment Positive Outcomes; Pfizer’s Once-Daily Oral GLP-1 Agonist Danuglipron; FDA Issues Complete Response Letter to Novo Nordisk; Arcutis’ ZORYVE® Cream 0.15% FDA Approval; NICE Recommends Ebglyss For Moderate To Severe Atopic Dermatitis
Immutep Announces Promising Outcomes for First-Line Treatment in PD-L1 Negative Head and Neck Squamous Cell Carcinoma Patients Immutep Limited announced positive results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial, evaluating eftilagimod alfa (efti) combined with MSD’s anti-PD-1 therapy KEYTR...
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