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The Swiss drugmaker raised its full-year guidance Tuesday projecting net sales to grow in the high-single to low double-digit range while reporting better-than-expected first-quarter results.
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CEO Hervé Hoppenot said Tuesday on an investor call that Escient Pharmaceuticals’ two lead assets “address large populations with a clear medical need” with a potential multibillion-dollar market opportunity.
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Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.
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Bouncing back from a previous rejection, ImmunityBio on Monday secured the FDA’s green light for its IL-15 superagonist Anktiva for non-muscle invasive bladder cancer.
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The regulator on Monday slapped Abeona Therapeutics with a Complete Response Letter for its investigational cell therapy pz-cel due to chemistry, manufacturing and controls issues.
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The U.S. Supreme Court on Monday indicated that it will not hear Vanda Pharmaceuticals’ petition in its patent case against Teva Pharmaceuticals regarding the former’s sleep-wake disorder drug Hetlioz.
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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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Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings.
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Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor
4/23/2024
Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.
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Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting
4/23/2024
Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
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Clarapath Forms Strategic Collaboration with Mayo Clinic to Advance Pathology Tissue Processing
4/23/2024
Clarapath, a medical robotics company transforming the way pathology laboratories process tissue, announced it has entered into a strategic collaboration with Mayo Clinic to propel a new era of laboratory automation.
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Epitel Receives FDA 510(k) Clearance for Two New Technologies: REMI Remote EEG Monitoring System for Ambulatory Use and REMI Vigilenz AI For Event Detection
4/23/2024
Epitel, a leader in AI technologies for patient-focused brain health solutions, announced today it received U.S. Food and Drug Administration (FDA) 510(k) clearances for two new innovative technologies: REMI™ Remote EEG Monitoring System for Ambulatory (at home) use and REMI Vigilenz™ AI For Event Detection.
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Multiply Labs Announces Upcoming Collaboration with Stanford Medicine’s Laboratory for Cell and Gene Medicine (LCGM) to Deploy Automated Systems For Cell Therapy Manufacturing
4/23/2024
Multiply Labs, a robotics company developing industry-leading automated manufacturing systems to produce individualized drugs, today announced its upcoming collaboration with Stanford Medicine’s Laboratory for Cell & Gene Medicine (LCGM) to demonstrate the potential of automation technology for cell therapy manufacturing.
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Medicure Receives US FDA Fast Track Designation for MC-1 for PNPO Deficiency
4/23/2024
Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH)(OTC PINK:MCUJF) announced today that through its subsidiary, Medicure International Inc., the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for MC-1, an investigational product for the prevention or treatment of seizures associated with pyridox(am)ine 5'-phosphate oxidase (PNPO) deficiency.
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Curio Digital Therapeutics Inc. Announces the U.S. Food and Drug Administration (FDA) Clearance of MamaLift Plus™, the First Prescription Digital Therapeutic Authorized for the Treatment of Postpartum Depression (PPD)
4/23/2024
Curio Digital Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted clearance to MamaLift PlusTM.
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Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors
4/23/2024
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved Lutathera® (lutetium Lu 177 dotatate) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.
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Curium Enrolls First Prostate Cancer Patients in its Phase 3 SOLAR Trials
4/23/2024
Curium, a world leader in nuclear medicine, announced today that it has successfully enrolled and scanned patients in its SOLAR clinical trials.
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Vanda Pharmaceuticals Reacts to U.S. Supreme Court's Denial of its Petition in HETLIOZ® ANDA Litigation
4/23/2024
Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Supreme Court denied Vanda's petition for a writ of certiorari in its HETLIOZ ® Abbreviated New Drug Application litigation against Teva Pharmaceuticals USA , Inc.
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Neurocrine Biosciences Reports Positive Phase 2 Data for NBI-1065845 in Adults with Major Depressive Disorder
4/23/2024
Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced positive topline data for its Phase 2 SAVITRI™ study. This randomized, double-blind, placebo-controlled dose-finding study assessed the efficacy and safety of NBI-1065845 in adult subjects with major depressive disorder (MDD).
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Egnyte to Host Fourth Annual Life Sciences Summit for Emerging Biotech Companies
4/23/2024
Egnyte, a leader in cloud content security and governance, will host its annual Life Sciences Summit on May 8, 2024. This year’s event will be a hybrid event, with Boston-based guests