TrakCel's OCELLOS Platform Chosen to Support Five Key Cell Therapy Products in 2024, Streamlining CGT Supply Chain Management

TrakCel, a provider of integrated cell and gene therapy (CGT) orchestration solutions for the precise management, control and tracking of CGTs has announce...

November 13, 2024 | Wednesday | News
Arcturus Therapeutics Receives FDA Green Light for Clinical Trial of sa-mRNA Vaccine Targeting Pandemic H5N1 Influenza

Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focus...

November 12, 2024 | Tuesday | News
ResQ Pharma Receives PDUFA Date for FDA Review of LipidRescue Kit for Life-Threatening Anesthetic Reactions

ResQ Pharma, Inc., a Chicago-based pharmaceutical company developing and commercializing innovative drug therapies, announced that it has received a P...

November 12, 2024 | Tuesday | News
FDA Grants Orphan Drug and Rare Pediatric Disease Designations to Ifetroban for Duchenne Muscular Dystrophy Cardiomyopathy

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company, announced  that the United States (U.S.) Food and D...

November 07, 2024 | Thursday | News
Ionis Pharmaceuticals Announces Phase 3 Study Design for ION582 in Angelman Syndrome Following FDA Alignment

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced the pivotal Phase 3 study design following successful alignment with the U.S. Food and...

November 07, 2024 | Thursday | News
European Medicines Agency Approves Dupixent for Treating Eosinophilic Esophagitis in Children Aged 1-11

The European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one year of age. Specifical...

November 07, 2024 | Thursday | News
Acadia Pharmaceuticals to Sell Rare Pediatric Disease Priority Review Voucher for $150 Million

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) announced that it entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority...

November 06, 2024 | Wednesday | News
Ionis Pharmaceuticals Announces FDA Acceptance of NDA for Donidalorsen, a Potential Prophylactic Treatment for Hereditary Angioedema

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New ...

November 05, 2024 | Tuesday | News
QIAGEN’s QIAstat-Dx Meningitis/Encephalitis Panel Cleared by FDA for Clinical Use

QIAstat-Dx Meningitis/Encephalitis Panel cleared in the U.S. for use in clinical settings to help diagnose central nervous system infections // Fourth ...

November 04, 2024 | Monday | News
Genentech Publishes Positive Phase III Results for Itovebi in Advanced Breast Cancer in NEJM

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that a detailed analysis of the positive Phase III INAVO120 results, evaluat...

November 01, 2024 | Friday | News
Roche Unveils Promising Data for Elecsys Amyloid Plasma Panel in Alzheimer’s Diagnosis at CTAD 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced new late-breaking data on its Elecsys Amyloid Plasma Panel (combination of pTau181 and ApoE4), for Alzhei...

November 01, 2024 | Friday | News
Eli Lilly Reports Positive Phase 3b Results for Donanemab, Reducing Amyloid-Related Edema in Alzheimer's Patients

Eli Lilly and Company (NYSE: LLY) announced positive results from the TRAILBLAZER-ALZ 6 Phase 3b study, showing a reduction in amyloid-related imaging...

October 30, 2024 | Wednesday | News
Novartis Secures FDA Accelerated Approval for Scemblix® in Newly Diagnosed CML Patients

Novartis announced that Scemblix® (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients wit...

October 30, 2024 | Wednesday | News
PL Developments Secures FDA Approval for Omeprazole OTC and Successfully Refinances Corporate Debt

PL Developments (PLD), a leader in the development, manufacturing, packaging, and distribution of consumer healthcare products, announced two significant m...

October 29, 2024 | Tuesday | News

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