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FDA Grants Breakthrough Status to Ionis’ Drug for Alexander Disease
Ionis Pharmaceuticals has received a significant boost in its neurology pipeline with the U.S. Food and Drug Administration granting Breakthrough Therapy designation to zilganersen, the…
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FDA Expands Approval of Lilly’s Jaypirca for Earlier CLL/SLL Treatment
Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has granted expanded approval for Jaypirca (pirtobrutinib) for adults with relapsed or refractory…
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Regeneron, Tessera Partner on Gene Writing Therapy for AATD
Regeneron Pharmaceuticals and Tessera Therapeutics have entered into a major global collaboration to advance TSRA-196, an investigational in vivo Gene Writing therapy designed to…
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FDA Grants Rare Pediatric Disease Status to Solid Biosciences’ FA Therapy
Solid Biosciences Inc. has received a significant regulatory boost as the U.S. Food and Drug Administration (FDA) granted Rare Pediatric Disease (RPD) designation to SGT-212, the…
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Novo Nordisk Alzheimer’s Trials Show No Benefit for Semaglutide
Novo Nordisk has reported top-line findings from its two major phase 3 Alzheimer’s disease trials, evoke and evoke+, revealing that oral semaglutide did not demonstrate superiority to…
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FDA Approves First Gene Therapy for Broad SMA Patient Population
The U.S. Food and Drug Administration (FDA) has approved Novartis’ Itvisma® (onasemnogene abeparvovec-brve) for children aged two years and older, as well as teens and adults, living…
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AstraZeneca to Invest $2 Billion in Major Maryland Expansion
AstraZeneca announced plans to invest $2 billion to significantly expand its manufacturing presence in Maryland, marking one of the company’s largest U.S. investments to date. The…
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EU Grants Conditional Approval for Roche’s One-Minute Subcutaneous Lunsumio in Follicular Lymphoma
Roche announced that the European Commission has granted conditional marketing authorisation for a new subcutaneous (SC) formulation of Lunsumio (mosunetuzumab) for adults with relapsed…
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Novartis to Build Major U.S. Manufacturing Hub in North Carolina
Novartis has announced a sweeping expansion of its U.S. operations, unveiling plans to establish a new flagship manufacturing hub in North Carolina that will feature full end-to-end…
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EU Approves First Subcutaneous Version of Keytruda for All Adult Indications
The European Commission has approved Merck’s new subcutaneous formulation of Keytruda, branded as KEYTRUDA SC, making it the first subcutaneous immune checkpoint inhibitor available in…
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FDA Approves AbbVie’s EPKINLY Combination for Relapsed or Refractory Follicular Lymphoma
The U.S. Food and Drug Administration (FDA) has approved AbbVie’s EPKINLY® (epcoritamab-bysp), a subcutaneously administered T-cell engaging bispecific antibody, in combination with…
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Johnson & Johnson to Acquire Halda Therapeutics for $3.05B to Expand Oncology Pipeline
Johnson & Johnson has announced a definitive agreement to acquire Halda Therapeutics, a clinical-stage biotech developing oral, targeted cancer therapies using its proprietary…
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UK Approves Monthly Maintenance Dosing for Alzheimer’s Drug Leqembi
Eisai and Biogen announced that the UK Medicines and Healthcare products Regulatory Agency has approved a once-every-four-weeks IV maintenance dosing regimen for Leqembi (lecanemab), an…
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Novartis Opens New Radioligand Therapy Manufacturing Facility in California to Boost U.S. Cancer…
Novartis has announced the opening of a new 10,000-square-foot radioligand therapy (RLT) manufacturing facility in Carlsbad, California — a major step in the company’s $23 billion,…
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FDA Approves Johnson & Johnson’s DARZALEX FASPRO as First Treatment for High-Risk Smoldering…
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as a single-agent therapy for adults…
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Merck Secures $700 Million from Blackstone to Advance Cancer Drug Development
Merck, known as MSD outside the U.S. and Canada, has entered into a $700 million funding agreement with Blackstone Life Sciences to support the development of sacituzumab tirumotecan…
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Eli Lilly to Invest $3 Billion in New Manufacturing Facility in the Netherlands
Eli Lilly and Company has announced plans to invest $3 billion in a new state-of-the-art manufacturing facility in Katwijk, the Netherlands, located within the Leiden Bio Science Park.…
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UCB Secures FDA Approval for KYGEVVI, the First-Ever Treatment for Ultra-Rare TK2 Deficiency
UCB, a global biopharmaceutical company, has received U.S. Food and Drug Administration (FDA) approval for KYGEVVI, a treatment for adults and pediatric patients suffering from…
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Novo Nordisk Makes $6.5 Billion Unsolicited Bid to Acquire Biotech Firm Metsera
Novo Nordisk has confirmed submitting an unsolicited proposal to acquire U.S.-based Metsera, Inc., a biotechnology company developing early- and mid-stage incretin and non-incretin…
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EU Approves Alexion’s Koselugo for Adults with Neurofibromatosis Type 1
Alexion, AstraZeneca Rare Disease, announced that the European Commission has approved Koselugo (selumetinib) for the treatment of symptomatic, inoperable plexiform neurofibromas (PN)…
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