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The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
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In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA's decisions in 2024.
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Orchard Therapeutics Receives FDA Approval of Lenmeldy™ (atidarsagene autotemcel), the Only Therapy for Eligible Children with Early-onset Metachromatic Leukodystrophy in the U.S.
3/18/2024
Orchard Therapeutics announced the U.S. Food and Drug Administration has approved Lenmeldy™, formerly known as OTL-200, for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile —collectively referred to as early-onset—metachromatic leukodystrophy.
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Sequel’s twiist™ Automated Insulin Delivery System Receives FDA 510(k) Clearance
3/18/2024
Sequel Med Tech, LLC, a company developing state-of-the-art insulin delivery technologies, announced its partner, DEKA Research & Development Corp., has received 510 clearance from the U.S. Food and Drug Administration for the innovative twiist™ Automated Insulin Delivery system powered by Tidepool.
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American Aires Announces Agreement with William Morris Endeavor Entertainment
3/18/2024
American Aires Inc. (CSE: WIFI) (OTC Pink: AAIRF) ("Aires" or the "Company"), a pioneer in cutting-edge technology designed to protect against electromagnetic radiation and optimize human health, is excited to announce a strategic partnership with William Morris Endeavor Entertainment, LLC ("WME"), a titan in entertainment, sports, and fashion.
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By votes of 11-0 and 8-3, respectively, an FDA advisory committee Friday deemed the risks of early death for both Johnson & Johnson’s Carvykti and Bristol Myers Squibb’s Abecma acceptable.
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Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is the first-ever approved therapy for metabolic dysfunction-associated steatohepatitis—a decision experts say could signal a sea change in treatment of the disease.
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The FDA approved Bristol Myers Squibb’s Breyanzi for chronic lymphocytic leukemia and small lymphocytic leukemia prior to Friday’s adcomm for the company’s other CAR-T therapy, Abecma.
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BMS and J&J will meet with the Oncologic Drugs Advisory Committee Friday to discuss their CAR-T therapies Abecma and Carvykti as the companies seek their approval as earlier lines of treatment.
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Despite skepticism from FDA reviewers, the Oncologic Drugs Advisory Committee on Thursday strongly supported Geron’s imetelstat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes.
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FDA Roundup: March 15, 2024
3/15/2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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The U.K. National Institute for Health and Care Excellence on Thursday recommended against funding Vertex Pharmaceuticals’ CRISPR-based sickle cell disease therapy Casgevy unless uncertainties can be cleared up.
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Geron Announces FDA Oncologic Drugs Advisory Committee Votes in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS
3/14/2024
Geron Corporation announced that the U.S. Food and Drug Administration Oncologic Drugs Advisory Committee voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
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FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population
3/14/2024
Global Liver Institute recognizes the importance of the first approval by the U.S. Food and Drug Administration of a medication for nonalcoholic steatosis.
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Salipro Biotech Obtains Grant for Key Patent from the European Patent Office
3/14/2024
Swedish biotech company Salipro Biotech AB announced that the European Patent Office has granted a further patent in Salipro Biotech's growing patent portfolio: European Patent EP 3 955 895 B1, entitled 'Production of Salipro® particles'.
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With an advisory committee meeting slated for Friday, the regulator has posted briefing documents in which it has raised concerns about early deaths in patients treated with Bristol Myers Squibb’s Abecma and Johnson & Johnson’s Carvykti.
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In a briefing document for Thursday’s advisory committee meeting, the FDA pointed to efficacy and safety issues with Geron’s New Drug Application for imetelstat in myelodysplastic syndromes.
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PureTech Receives Orphan Drug Designation for LYT-200 in Acute Myeloid Leukemia
3/13/2024
PureTech Health plc, a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, announced that the U.S. Food and Drug Administration has granted orphan drug designation to LYT-200 for the treatment of AML.
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PepGen Receives U.S. FDA Orphan Drug and Rare Pediatric Disease Designations for PGN-EDO51 for the Treatment of Duchenne Muscular Dystrophy
3/13/2024
PepGen Inc. announced that the U.S. Food and Drug Administration granted both orphan drug and rare pediatric disease designations for PGN-EDO51, an investigational therapeutic for Duchenne muscular dystrophy patients whose mutations are amenable to an exon 51 skipping approach.
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IMUNON Files IND Application to Begin Human Testing of IMNN-101
3/13/2024
IMUNON, Inc. announces it has filed an Investigational New Drug application with the U.S. Food and Drug Administration for IMNN-101 for a Phase 1 clinical study with a seasonal COVID-19 booster vaccine.