Roche Receives FDA Approval for Evrysdi® Tablet for Spinal Muscular Atrophy

 Roche  announced  that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for an Evrysdi® (risdiplam...

February 13, 2025 | Thursday | News
Pfizer Receives FDA Approval for ADCETRIS® Combination Therapy in Relapsed/Refractory Large B-Cell Lymphoma

 Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for AD...

February 13, 2025 | Thursday | News
SpringWorks Therapeutics Secures FDA Approval for GOMEKLI™ to Treat Neurofibromatosis Type 1 with Plexiform Neurofibromas

SpringWorks Therapeutics, Inc. a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced  that the U.S. Food ...

February 12, 2025 | Wednesday | News
Celltrion Secures FDA Approval for AVTOZMA® Biosimilar to ACTEMRA® with Both IV and SC Formulations

Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) ...

February 12, 2025 | Wednesday | News
CSL’s HEMGENIX® Delivers Long-Term Bleed Protection for Hemophilia B with Four-Year Data from HOPE-B Study

 Global biotechnology leader CSL announced the four-year results from the pivotal HOPE-B study confirming the long-term durability and safety of a one...

February 10, 2025 | Monday | News
Regeneron’s EYLEA HD® 8 mg Shows Promise for Retinal Vein Occlusion in Phase 3 QUASAR Trial

Regeneron Pharmaceuticals, Inc.announced the first presentation of positive results from the Phase 3 QUASAR trial investigating EYLEA HD® (afliber...

February 10, 2025 | Monday | News
AbbVie Wins FDA Nod for EMBLAVEO™, Tackling Antimicrobial-Resistant Infections

AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EMBLAVEO™ (aztreonam and avibactam), as the first and only fixed-...

February 10, 2025 | Monday | News
Genentech's Gazyva® Demonstrates Significant Improvement in Lupus Nephritis in Phase III REGENCY Trial

Genentech, a member of the Roche Group, announced that a detailed analysis of its Phase III REGENCY trial of Gazyva® (obinutuzumab) in people with acti...

February 10, 2025 | Monday | News
Partner Therapeutics Announces NEJM Publication of Phase 2 eNRGy Trial Results for Zenocutuzumab-Zbco (BIZENGRI®)

Partner Therapeutics, Inc. (PTx), a private, fully-integrated biotechnology company announced  that the New England Journal of Medicine (NEJ...

February 06, 2025 | Thursday | News
Zoetis Updates U.S. Label for Librela® (bedinvetmab) Following Post-Approval Experience

Zoetis Inc. announced that it has updated the U.S. label for Librela® (bedinvetmab injection), following its submission of a supplement to the U.S...

February 05, 2025 | Wednesday | News
Roche Announces FDA Approval of Susvimo® for Diabetic Macular Edema, Offering a Treatment with Fewer Injections

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced  that the US Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/...

February 05, 2025 | Wednesday | News
Roche's PATHWAY® Anti-HER2 Test Gains FDA Approval to Identify HER2-Ultralow Metastatic Breast Cancer Patients for ENHERTU® Treatment

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced  that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® ant...

February 03, 2025 | Monday | News
Celltrion Announces FDA Approval of AVTOZMA® (CT-P47) as Biosimilar to ACTEMRA® for Multiple Indications

Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved AVTOZMA® (CT-P47, tocilizumab-anoh) in both an intravenous (IV) ...

January 31, 2025 | Friday | News
Mesoblast Advances U.S. Commercial Launch of Ryoncil® for Pediatric SR-aGvHD, with Key Milestones Ahead

Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases,  provided an update on the progres...

January 31, 2025 | Friday | News

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