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The Pharma Data

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The Pharma Data
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European Commission Grants Approval to Moderna’s RSV Vaccine, mRESVIA

  • The Pharma Data
  • August 24, 2024

Moderna, Inc. (NASDAQ) has announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA vaccine designed to protect adults aged 60 and older from lower…

Read MoreEuropean Commission Grants Approval to Moderna’s RSV Vaccine, mRESVIA
  • Regulatory

Pfizer and BioNTech Get U.S. FDA Approval for Omicron KP.2-Adapted COVID-19 Vaccine

  • The Pharma Data
  • August 24, 2024

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) have announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application for their COMIRNATY® COVID-19…

Read MorePfizer and BioNTech Get U.S. FDA Approval for Omicron KP.2-Adapted COVID-19 Vaccine
  • News

China Approves PADCEV™ for Advanced Urothelial Cancer

  • The Pharma Data
  • August 24, 2024

Astellas Pharma Inc. (TSE: 4503), led by President and CEO Naoki Okamura, has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted…

Read MoreChina Approves PADCEV™ for Advanced Urothelial Cancer
  • News

TEPKINLY® (epcoritamab) Gets Second European Approval for Relapsed/Refractory Follicular Lymphoma

  • The Pharma Data
  • August 24, 2024

Genmab A/S (Nasdaq: GMAB) has announced that the European Commission (EC) has granted conditional marketing authorization for TEPKINLY® (epcoritamab) as a monotherapy for adult patients with relapsed or refractory (R/R)…

Read MoreTEPKINLY® (epcoritamab) Gets Second European Approval for Relapsed/Refractory Follicular Lymphoma
  • Business

BioMarin Appoints New Leaders in R&D and Business Development

  • The Pharma Data
  • August 24, 2024

BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) has announced key leadership changes in its research and development and business development teams. Effective September 30, Greg Friberg, M.D., will join the company as…

Read MoreBioMarin Appoints New Leaders in R&D and Business Development
  • Business

WuXi Biologics Announces Strong Interim Results for 2024

  • The Pharma Data
  • August 24, 2024

WuXi Biologics (Cayman) Inc. (“WuXi Biologics” or “the Group”, stock code: 2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO) providing comprehensive solutions for biologics discovery, development, and…

Read MoreWuXi Biologics Announces Strong Interim Results for 2024
  • Press Releases

Viatris Unveils Late-Breaking Abstract on Cenerimod at the 26th APLAR Annual Congress

  • The Pharma Data
  • August 24, 2024

Viatris Inc. (NASDAQ: VTRS), a leading global healthcare company, today presented results from its Phase 2 study of cenerimod (ACT-333441) as a late-breaking abstract at the 26th Asia-Pacific League of…

Read MoreViatris Unveils Late-Breaking Abstract on Cenerimod at the 26th APLAR Annual Congress
  • Research

Jazz Pharmaceuticals Updates on Phase 3 Trial of Cannabidiol for Epilepsy in Japan

  • The Pharma Data
  • August 24, 2024

Jazz Pharmaceuticals plc (Nasdaq: JAZZ) has announced the top-line results from a Phase 3 open-label, single-arm trial conducted in Japan. The study assessed the safety and efficacy of their cannabidiol…

Read MoreJazz Pharmaceuticals Updates on Phase 3 Trial of Cannabidiol for Epilepsy in Japan
  • Press Releases

Elanco Animal Health to Expand Production Capabilities at Kansas Manufacturing Facility

  • The Pharma Data
  • August 24, 2024

Elanco Animal Health Incorporated (NYSE: ELAN) has announced a significant expansion of its biologics manufacturing facility in Elwood, Kansas. The 25,000-square-foot expansion represents a $130 million investment that will be…

Read MoreElanco Animal Health to Expand Production Capabilities at Kansas Manufacturing Facility
  • News

Lupin Gains Health Canada Approval for Pegfilgrastim Biosimilar

  • The Pharma Data
  • August 24, 2024

Lupin Limited, a leading global pharmaceutical company, has announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim. The product, to be marketed under the brand name…

Read MoreLupin Gains Health Canada Approval for Pegfilgrastim Biosimilar
  • Regulatory

Bristol Myers Squibb’s sBLA Accepted by FDA for First-Line Treatment of Unresectable Hepatocellular Carcinoma

  • The Pharma Data
  • August 22, 2024

Bristol Myers Squibb (NYSE: BMY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with Yervoy®…

Read MoreBristol Myers Squibb’s sBLA Accepted by FDA for First-Line Treatment of Unresectable Hepatocellular Carcinoma
  • News

OTEZLA® (Apremilast) Now Available in the U.S. for Moderate to Severe Pediatric Plaque Psoriasis Treatment

  • The Pharma Data
  • August 22, 2024

Amgen (NASDAQ: AMGN) has announced that Otezla® (apremilast) is now available in the U.S. for pediatric use. Earlier this year, the U.S. Food and Drug Administration (FDA) approved Otezla for…

Read MoreOTEZLA® (Apremilast) Now Available in the U.S. for Moderate to Severe Pediatric Plaque Psoriasis Treatment
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