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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 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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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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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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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
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Generic Drugs Market Size to Worth Around USD 779.68 Bn by 2033
4/23/2024
A recent market report published by nova one advisor, the global generic drugs market size was estimated at USD 465.19 billion in 2023 and is expected to be worth around USD 779.68 billion by 2033 with a CAGR of 5.3% from 2024 to 2033.