European Commission Poised to Authorize Omicron KP.2-Adapted COVID-19 Vaccine for Individuals Aged 6 Months and Older

Upon authorization by the European Commission (EC), the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and o...

September 23, 2024 | Monday | News
Novo Nordisk’s Wegovy® Receives Positive Opinion from EMA for Label Update Reflecting Reduced Heart Failure Symptoms

Novo Nordisk announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opin...

September 20, 2024 | Friday | News
Astellas Launches DIGITIVA™, a New Digital Health Solution for Heart Failure Management

New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring -...

September 19, 2024 | Thursday | News
Vidac Pharma Secures Broad U.S. Patent for Pioneering Cancer Treatment Mode of Action

Vidac Pharma Holdings Plc., a clinical-stage oncology biopharmaceutical company pioneering a novel class of cancer treatments,  announces that the U...

September 19, 2024 | Thursday | News
Novartis Announces FDA Approval of Kisqali® for Expanded Use in Early Breast Cancer, Doubling Eligible Patient Population

– Novartis announced that the U.S. Food and Drug Administration (FDA) has approved Kisqali® (ribociclib) in combination with an aromata...

September 18, 2024 | Wednesday | News
Valneva Seeks to Expand IXCHIQ® Chikungunya Vaccine Use to Adolescents in Europe and Canada

Valneva SE , a specialty vaccine company, announced the submission of label extension applications to the European Medicines Agency (EMA) and Hea...

September 18, 2024 | Wednesday | News
Nicox’s ZERVIATE® Approved for Ocular Itching in China, Set to Launch with Ocumension Therapeutics

Nicox’s partner, Ocumension Therapeutics, has received approval for ZERVIATE® for ocular itching in China ZERVIATE® launch in China wil...

September 18, 2024 | Wednesday | News
BeiGene Secures Israeli Ministry of Health Approval for TEVIMBRA® in Treating Esophageal Squamous Cell Carcinoma

BeiGene, a global oncology company, announced that the Israeli Ministry of Health (IL MOH) has approved TEVIMBRA® (tislelizumab) as monotherapy for t...

September 18, 2024 | Wednesday | News
Nuance Pharma Expands Bentrio® Nasal Spray Reach Across East and South East Asia

Altamira Therapeutics announces the extension of its exclusive license with Nuance Pharma to cover Singapore, Malaysia, Thailand, Philippines, Indonesia,...

September 17, 2024 | Tuesday | News
T2 Biosystems Gains FDA Clearance for Pediatric Use of T2Candida® Panel

T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance gene...

September 17, 2024 | Tuesday | News
FDA Approves Roche’s OCREVUS ZUNOVO™ for Subcutaneous MS Treatment, Expanding Access for Patients

OCREVUS ZUNOVO™ has the potential to expand treatment options to centres without IV infrastructure or with IV constraints, like at a doctor's off...

September 16, 2024 | Monday | News
Japan Approves World's First Self-Amplifying mRNA COVID-19 Vaccine, KOSTAIVE®, Targeting Omicron JN.1 Subvariants

Approval underscores CSL and Arcturus Therapeutics' commitment to delivering disruptive technologies to combat COVID-19 and other respiratory viral disea...

September 13, 2024 | Friday | News
FDA Grants Seven Years of Market Exclusivity to YORVIPATH for Treating Hypoparathyroidism in Adults

U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in...

September 12, 2024 | Thursday | News
FDA Issues Warning Letters to Two Chinese Testing Labs Over Data Integrity and Animal Care Violations

Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing U.S. Food and Drug Administration issued warni...

September 12, 2024 | Thursday | News

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