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Preventive Medicine 2023

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Preventive Medicine 2023

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Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation

  • ByThe Pharma Data
  • OnMarch 22, 2023

Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will offer US patients reduced injection volume in citrate-free formulation…

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  • Business

Kite’s Yescarta® CAR T-cell Therapy Demonstrates a Statistically Significant Improvement in Overall Survival for Initial Treatment of Relapsed/Refractory Large B-cell Lymphoma

  • ByThe Pharma Data
  • OnMarch 22, 2023

Kite, a Gilead Company (Nasdaq: GILD), today announced the primary overall survival (OS) analysis results of the Phase 3 ZUMA-7 study. The results showed a statistically significant improvement for Yescarta…

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  • Regulatory

Nubeqa™ (darolutamide) approved for additional prostate cancer indication in China

  • ByThe Pharma Data
  • OnMarch 20, 2023

Nubeqa™ now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer / Additional indication based on data from the pivotal Phase III ARASENS trial   The Chinese…

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  • Press Releases

EISAI PUBLISHES SOCIETAL VALUE OF LECANEMAB USING PHASE 3 CLARITY AD DATA IN PEER-REVIEWED NEUROLOGY AND THERAPY JOURNAL

  • ByThe Pharma Data
  • OnMarch 20, 2023

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced the publication of updated results from an evaluation estimating the societal value of anti-amyloid-beta (Aβ) protofibril* antibody lecanemab (generic…

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  • Business

New four year data for Roche’s Evrysdi reinforce long-term efficacy and safety profile in some of the most severely affected people with types 2 and 3 spinal muscular atrophy (SMA)

  • ByThe Pharma Data
  • OnMarch 20, 2023

 Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new long-term data for Evrysdi® (risdiplam) in a broad range of people aged 2-25 years with spinal muscular atrophy (SMA) from the…

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  • Business

Novartis shares Zolgensma long-term data demonstrating sustained durability up to 7.5 years post-dosing; 100% achievement of all assessed milestones in children treated prior to SMA symptom onset

  • ByThe Pharma Data
  • OnMarch 20, 2023

Novartis today presented new data which underscore the transformational and sustained benefit of Zolgensma® (onasemnogene abeparvovec), an essential one-time gene therapy for the treatment of spinal muscular atrophy (SMA). Latest data from…

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  • Business

Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer

  • ByThe Pharma Data
  • OnMarch 18, 2023

Novartis today announced the U.S. Food and Drug Administration (FDA) granted approval for Tafinlar® (dabrafenib) + Mekinist® (trametinib) for the treatment of pediatric patients 1 year of age and older with low-grade…

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  • Press Releases

TREMFYA® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis

  • ByThe Pharma Data
  • OnMarch 18, 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data, showing that initiation of TREMFYA® (guselkumab) was associated with greater treatment persistencea compared to secukinumab or ixekizumab in bio-naïve and…

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  • Business

Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

  • ByThe Pharma Data
  • OnMarch 18, 2023

Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI®…

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  • Regulatory

FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product

  • ByThe Pharma Data
  • OnMarch 18, 2023

Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff, a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product…

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  • Business

FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™

  • ByThe Pharma Data
  • OnMarch 18, 2023

The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is May 2023 Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and…

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  • Press Releases

Sanofi cuts U.S. list price of Lantus®, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance

  • ByThe Pharma Data
  • OnMarch 18, 2023

Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 Units/mL, its most widely prescribed insulin in the U.S., by 78 percent. The company also…

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Pediatric Academic Societies Meetimg (PAS) 2023
Global Pharma & Drug Delivery Summit 2023
ACPM 2023
ECBIP 2023
The 15th Paris Hepatology Conference 2023
ASGBI annual conference 2023
37th NASPAG Annual Clinical & Research Meeting 2023
18th Congress MESOT 2023
AMGA’s 2023 Annual Conference (AC23) 

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