Press Releases

Teva Pharmaceuticals, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today the FDA approval and U.S. launch of a generic version of Saxenda®1 (liraglutide injection). “With this approval, and by launching a generic for Saxenda® (liraglutide injection), we will provide patients in the U.S. the first ever generic GLP-1 product specifically indicated for weight loss,” said Ernie Richardsen, SVP, Head of U.S. Commercial

Vanda Pharmaceuticals Inc. today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for VGT-1849B, a selective peptide nucleic acid-based JAK2 inhibitor for the treatment of polycythemia vera (PV). PV is a chronic myeloproliferative disorder characterized by aberrant hematopoiesis of myeloid lineage with exuberant red cell production and increased release of pro-inflammatory cytokines. More than 95% of PV patients harbor the JAK2 V617F gai

Heidelberg Pharma AG, a clinical stage biotech company developing innovative Antibody Drug Conjugates (ADCs), today announced that its licensing partner Telix Pharmaceuticals Limited, headquartered in Melbourne, Australia, (ASX: TLX, NASDAQ: TLX; Telix) was informed by the US Food and Drug Administration (FDA) that deficiencies relating to the Chemistry, Manufacturing, and Controls (CMC) package have been identified. At the end of December 2024, a Biologic License Application (BLA)

Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Applications (sBLA) for the 2025-2026 formulas for Spikevax® and mNEXSPIKE®, targeting the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19. The updated formula for Spikevax is now approved for individuals 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, a

Gilead Sciences, Inc. today announced that the European Commission (EC) has granted marketing authorization for Yeytuo® (lenacapavir)—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg. Yeytuo is the first and only twice-yearly PrEP option to be approved for use in the European Unio

AbbVie and Gilgamesh Pharmaceuticals Inc. ("Gilgamesh") today announced a definitive agreement under which AbbVie will acquire Gilgamesh's lead investigational candidate, currently in clinical development for the treatment of patients with moderate-to-severe major depressive disorder (MDD). Psychedelic compounds, including 5-HT2A receptor agonists, have gained recognition as potential treatments for mental health disorders, such as MDD, because of their demonstrat

Thermo Fisher Scientific Inc., the world leader in serving science, today announced the grand opening of its innovative manufacturing center of excellence facility in Mebane, N.C. The new 375,000-square-foot carbon neutral site will be capable of producing at least 40 million laboratory pipette tips per week, helping to ensure that life-saving medicines and therapies continue to be developed and produced in the U.S. for decades to come. As a global leader in life sciences manufactur

Kite, a Gilead Company, today announced that it has entered into a definitive agreement to acquire Interius BioTherapeutics, a privately held biotechnology company developing in vivo CAR therapeutics, for $350 million. This acquisition complements Kite's expertise in cell therapy by incorporating Interius's integrating in vivo platform. This approach enables the generation of CAR T-cells directly within the patient’s body and may offer a more durable and long-lasting t

Ginkgo Bioworks which is building the leading platform for cell programming and biosecurity, today announced that its Datapoints offering has entered into a new strategic partnership with Inductive Bio and Tangible Scientific to make AI-driven lab-in-the-loop drug discovery broadly accessible across the industry. The partnership aims to deliver capabilities that previously required massive platform investments by combining high-throughput experimental workflows, streamlined compound managemen

Santhera Pharmaceuticals announces the signing of an exclusive agreement with Uniphar to manage the distribution of AGAMREE® (vamorolone) in the United Arab Emirates, the Kingdom of Saudi Arabia, Kuwait, Oman and Bahrain, for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. Sales are expected to begin on a named patient basis in Q1 2026, with broader commercial sales anticipated in late 2026 following market authorization and prici