Innovent Biologics and Roche Partner to Advance Novel DLL3-Targeted ADC for Small Cell Lung Cancer

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...

January 02, 2025 | Thursday | News
Novartis Announces Positive Phase III STEER Study Results for OAV101 IT in Spinal Muscular Atrophy Type 2 Patients

Novartis announced positive topline results from the Phase III STEER study. This pivotal study assessed the efficacy and safety of investigational intrathe...

December 31, 2024 | Tuesday | News
BMS Gains FDA Approval for Opdivo Qvantig, First Subcutaneous PD-1 Inhibitor with Three-Minute Administration

-Bristol Myers Squibb (NYSE: BMY)  announced that the U.S. Food and Drug Administration (FDA) granted approval for Opdivo Qvantig™&nbs...

December 30, 2024 | Monday | News
FDA Approves First Generic of Victoza (Liraglutide) for Type 2 Diabetes, Expanding Access to Affordable Treatment

the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like pep...

December 24, 2024 | Tuesday | News
Breaking Down "Novel" Drugs: FDA’s 2024 Approval Highlights

What are "Novel" Drugs? "Novel" drugs are new drugs never before approved or marketed in the U.S.   The term "novel" drugs refers to medications ...

December 23, 2024 | Monday | News
FDA Approves ALYFTREK® (Vanzacaftor/Tezacaftor/Deutivacaftor) as Once-Daily Treatment for Cystic Fibrosis

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced that the U.S. Food and Drug Administration (FDA) has approved ALYFTREK (v...

December 21, 2024 | Saturday | News
FDA Approves Zepbound® (Tirzepatide) as First Treatment for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity

Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) approved Zepbound® (tirzepatide) as the fir...

December 21, 2024 | Saturday | News
FDA Approves BRAFTOVI® Combination Therapy for First-Line Treatment of Metastatic Colorectal Cancer with BRAF V600E Mutation

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI® (encorafenib) in combination with cetuxi...

December 21, 2024 | Saturday | News
FDA Approves Ionis’ TRYNGOLZA™ as the First Treatment for Familial Chylomicronemia Syndrome (FCS)

 Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) announced that the U.S. Food and Drug Administration (FDA) has approved TRYNGOLZA™ (o...

December 20, 2024 | Friday | News
Smith+Nephew Expands CORI◊ Surgical System Portfolio with FDA-Cleared CORIOGRAPH Pre-Op Planning for Hip Arthroplasty

Latest expansion to the CORI◊ Surgical System portfolio provides a personalized solution for patients and surgeons Smith+Nephew (LSE:SN, NYSE:SNN),...

December 20, 2024 | Friday | News
European Commission Grants Orphan Medicinal Product Designation to Mitapivat for Sickle Cell Disease

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases...

December 19, 2024 | Thursday | News
Regeneron’s EYLEA HD® Achieves Key Milestone in Phase 3 QUASAR Trial for Macular Edema Due to Retinal Vein Occlusion

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the primary endpoint was met in the Phase 3 QUASAR trial investigating EYLEA HD® (af...

December 18, 2024 | Wednesday | News
Merck Announces FDA Acceptance of BLA for Clesrovimab (MK-1654), Investigational Monoclonal Antibody for Infant RSV Prevention

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics L...

December 18, 2024 | Wednesday | News
Jaypirca® (Pirtobrutinib) Gains Approval in China for Relapsed or Refractory Mantle Cell Lymphoma

Jaypirca®, a highly selective kinase inhibitor, utilizes a novel non-covalent binding mechanism to re-establish BTK inhibition in mantle cell lymphoma ...

December 16, 2024 | Monday | News

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