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• Sangamo Therapeutics Receives U.S. FDA Fast Track Designation for Isaralgagene Civaparvovec for the Treatment of Fabry Disease

  5/22/2023

  Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.

• BioCryst Announces Approval of ORLADEYO® (berotralstat) by the Public Health Institute of Chile

  5/22/2023

  BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Public Health Institute (ISP) of Chile has granted marketing authorization for oral, once-daily ORLADEYO ® (berotralstat) for the prophylaxis of hereditary angioedema (HAE) attacks in patients 12 years of age or older.

• AVROBIO Announces Agreement to Sell Cystinosis Gene Therapy Program for $87.5 Million

  5/22/2023

  AVROBIO, Inc today announced an agreement to sell its investigational hematopoietic stem cell (HSC) gene therapy program for the treatment of cystinosis to Novartis for $87.5 million in cash.

• Lilly ESG Report Highlights Progress Towards Sustainability Goals

  5/22/2023

  Eli Lilly and Company released its latest Environmental, Social and Governance report showing progress towards the company's ambitious sustainability goals, which are critical to maintaining a strong and resilient company.

• GenScript to Debut Expanded Synthetic Biology Product Line at SynBioBeta 2023

  5/22/2023

  GenScript Biotech Corporation, the world's leading provider of life-science research tools and services, is a sponsor of this year's SynBioBeta Conference in Oakland, California.

• Dupixent® (dupilumab) Late-breaking Phase 3 COPD Results Presented at ATS and Simultaneously Published in the New England Journal of Medicine

  5/21/2023

  Regeneron Pharmaceuticals, Inc. and Sanofi presented positive Phase 3 results evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation.

• Press Release: Dupixent® (dupilumab) late-breaking Phase 3 COPD results presented at ATS and simultaneously published in the New England Journal of Medicine

  5/21/2023

  Positive Phase 3 results evaluating the investigational use of Dupixent® compared to placebo in adults currently on maximal standard-of-care inhaled therapy with uncontrolled chronic obstructive pulmonary disease and evidence of type 2 inflammation were shared in the 2023 American Thoracic Society International Conference session “New England Journal of Medicine and JAMA.

• Alnylam Presents 18-Month Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy

  5/20/2023

  Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced new results from an interim analysis of exploratory data from the open-label extension period of the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy.

• Thermo Fisher Scientific Expands Steriles Manufacturing and Research Capabilities in Asia-Pacific Region

  5/19/2023

  Thermo Fisher Scientific, the world leader in serving science, has opened a new sterile drug facility in Singapore that will better enable customers to deliver new medicines and vaccines in the Asia-Pacific market.

• EPKINLY™ (epcoritamab-bysp) Approved by U.S. FDA as the First and Only Bispecific Antibody to Treat Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

  5/19/2023

  AbbVie announced that the U.S. Food and Drug Administration has approved EPKINLYTM, as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma, after two or more lines of systemic therapies.

• High School Scientists and Engineers Win Nearly $9 Million at the Regeneron International Science and Engineering Fair 2023

  5/19/2023

  Regeneron Pharmaceuticals, Inc. and Society for Science announced that Kaitlyn Wang, 17, of San José, CA, won the $75,000 top award in the 2023 Regeneron International Science and Engineering Fair, the world's largest global pre-college science and engineering competition, for a project that explored planets that orbit very close around their suns.

• Plandai Subsidiary ByoPlanet Announces Strategic Distribution Agreement with Merck Animal Health

  5/19/2023

  ByoPlanet is excited to announce the establishment of a comprehensive one-year distribution agreement with Merck Animal Health, a global leader in animal health solutions and a division of Merck & Co.

• Thermo Fisher Scientific Announces FDA Clearance of Breakthrough Immunoassays to Aid in the Risk Assessment of Preeclampsia

  5/19/2023

  Thermo Fisher Scientific Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

• Stereotaxis and Abbott Announce Global Collaboration Combining Leading Mapping and Robotic Technologies to Improve Treatment of Abnormal Heart Rhythms

  5/19/2023

  Stereotaxis (NYSE: STXS) today announced a global collaboration with Abbott (NYSE: ABT) to integrate Abbott’s EnSite™ X EP System with Stereotaxis’ Robotic Magnetic Navigation systems.

• CureVac Announces Developments in Patent Litigation with Pfizer/BioNTech

  5/19/2023

  Motion to transfer U.S. litigation to Eastern District of Virginia granted at CureVac's request and expected to significantly accelerate U.S. litigation timeline.

• Abbott Receives FDA Approval for TactiFlex™ Ablation Catheter for Treatment of Abnormal Heart Rhythm

  5/19/2023

  Abbott (NYSE: ABT) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's TactiFlex™ Ablation Catheter, Sensor Enabled™, the world's first ablation catheter with a flexible tip and contact force technology.

• Phase 1/2 Interim Data on Moderna's mRNA-3927, an Investigational mRNA Therapy for Propionic Acidemia (PA), Presented at the 2023 ASGCT Annual Meeting

  5/19/2023

  First clinical trial reporting results of an mRNA therapeutic for intracellular protein replacement.

• EMA validates marketing authorisation application for efanesoctocog alfa for treatment of haemophilia A

  5/19/2023

  Sobi announced that the European Medicines Agency has accepted and validated a marketing authorisation application for efanesoctocog alfa, a new class of high-sustained FVIII developed for the treatment of people with haemophilia A of all age groups.

• FDA Advisory Committee Votes in Support of Approval for Pfizer’s Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization

  5/18/2023

  Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the efficacy and safety of its unadjuvanted bivalent respiratory syncytial virus (RSV) prefusion F vaccine candidate RSVpreF or PF-06928316.

• Abbott Receives FDA Clearance for Assert-IQ™ Insertable Cardiac Monitor to Help Doctors Monitor People's Heart Rhythms Long-Term

  5/18/2023

  Abbott (NYSE: ABT) today announced its Assert-IQ™ insertable cardiac monitor (ICM) has received U.S. Food and Drug Administration (FDA) clearance, giving physicians a new option for diagnostic evaluation and long-term monitoring of people experiencing irregular heartbeats.