news
Nov 19, 2024
FDA Approves PTC’s AADC Gene Therapy; DUPIXENT sBLA Acceptance for Urticaria; CHMP Recommends TAGRISSO for EGFR Lung Cancer; FDA Approves DANZITEN for CML; Syndax Wins FDA Approval for REVUFORJ in Acute Leukemia
FDA Approves AADC Deficiency Gene Therapy by PTC Therapeutics PTC Therapeutics, Inc. has secured FDA accelerated approval for KEBILIDI (eladocagene exuparvovec-tneq), marking a historic milestone as the first-ever gene therapy directly administered to the brain in the United States. This innovative therapy addre...
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Nov 12, 2024
AUCATZYL Approved for R/R B-ALL; FDA Accepts NDA for Unicycive’s Oxylanthanum Carbonate; AstraZeneca and Amgen Report Positive Results in Chronic Rhinosinusitis; Nipocalimab Granted Breakthrough Designation for Sjögren’s Disease; AbbVie’s Schizophrenia Drug Fails Phase Studies
FDA Approves Autolus's AUCATZYL for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia Autolus Therapeutics has achieved a significant milestone with FDA approval for AUCATZYL (obecabtagene autoleucel), a next-generation CAR T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic le...
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Nov 05, 2024
Prolong’s PP-007 Fast-Tracked for Stroke; FDA Expands JYLAMVO Pediatric Approval; Corcept’s Cushing’s Drug Shows Positive Phase III Results; ESSA Halts Phase II Study of Masofaniten for Prostate Cancer; SCEMBLIX Approved for Leukemia
Prolong Pharmaceuticals Secures FDA Fast Track for PP-007 in Stroke Therapy Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, announced that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has been granted Fast Track designation by the FDA for the treatment of a...
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Oct 29, 2024
FDA Grants Orphan Status to MDL-101 for LAMA2-CMD; Pfizer’s ABRYSVO Approved for High-Risk Adults (18-59); KIND’s AND017 Gains Orphan Designation for Sickle Cell Disease; HiberCell’s HC-7366 Fast-Tracked for AML; ORLYNVAH Approved for Uncomplicated UTIs
FDA Grants Orphan Drug Status to MDL-101 for LAMA2-CMD Treatment Modalis Therapeutics Corporation has received Orphan Drug Designation (ODD) from the FDA for MDL-101, its promising treatment for congenital muscular dystrophy type 1A (LAMA2-CMD). This designation is a significant step, aimed at fostering the deve...
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Oct 15, 2024
Astellas & AviadoBio’s Exclusive Deal for AVB-101; GSK’s Depemokimab Shows Positive Results for Nasal Polyps; Lilly’s Mirikizumab Outperforms Ustekinumab in Crohn’s Study; TREMFYA Delivers Strong Results in Crohn’s & Colitis; ENHERTU Approved in China for HER2-Mutant NSCLC.
Astellas & AviadoBio Sign Exclusive Deal for Gene Therapy AVB-101 in Frontotemporal Dementia AviadoBio Ltd. and Astellas Pharma Inc. have announced a strategic partnership under an exclusive option and license agreement for AVB-101, an investigational AAV-based gene therapy currently in Phase I/II developmen...
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Oct 08, 2024
OPDIVO Approved for Resectable NSCLC; Palvella Gets $2.6M FDA Grant; First Patient Dosed in UGN-103 Bladder Cancer Trial; Recordati Acquires ENJAYMO for $825 Million; AIRSUPRA Reduces Severe Asthma Exacerbations
FDA Approves Perioperative OPDIVO Plus Chemotherapy for Resectable NSCLC The FDA has granted approval to Bristol Myers Squibb’s OPDIVO (nivolumab) for the treatment of adult patients with resectable non-small cell lung cancer (NSCLC), specifically targeting tumors that are 4 cm or larger or node-positive and hav...
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Oct 01, 2024
IntraBio’s AQNEURSA Niemann-Pick Disease Approval; FDA Approves Novel Schizophrenia Drug After 35 Years; Selpercatinib Gets FDA Nod for RET-Mutated MTC; DUPIXENT Receives First-Ever COPD Approval; Pfizer Withdraws OXBRYTA for Sickle Cell Disease from Global Market
IntraBio's AQNEURSA Receives Historic FDA Approval for Niemann-Pick Disease Type C Treatment IntraBio Inc. has received approval from the FDA for AQNEURSA (levacetylleucine), marking a significant milestone in the treatment of neurological manifestations of Niemann-Pick disease type C in both adults and pe...
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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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