Novartis Receives FDA Accelerated Approval for Vanrafia® in Treatment of Primary IgA Nephropathy

Novartis announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia® (atrasentan), a potent and selective e...

April 03, 2025 | Thursday | News
Genentech Reports Phase III MUSETTE Trial Results for Ocrevus® Showing No Additional Benefit from Higher Dose in Relapsing MS

Genentech, a member of the Roche Group, announced  that the Phase III MUSETTE trial comparing a high dose of Ocrevus® (ocrelizumab) intraveno...

April 03, 2025 | Thursday | News
Biogen’s BIIB080 Receives FDA Fast Track Designation for Alzheimer’s Disease Treatment

Biogen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to BIIB080, an investigational antisense oli...

April 03, 2025 | Thursday | News
Roche Reports Phase III MUSETTE Trial Results Showing No Additional Benefit from Higher Dose of OCREVUS® in Relapsing MS

Roche announced that the Phase III MUSETTE trial comparing a high dose of OCREVUS® (ocrelizumab) intravenous (IV) infusion to the currently approved OC...

April 03, 2025 | Thursday | News
Yingli Pharma Receives FDA Clearance to Launch Phase 3 Trial for Linperlisib in Relapsed/Refractory PTCL

Shanghai Yingli Pharmaceutical Co., Ltd., a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune dis...

April 02, 2025 | Wednesday | News
Inventiva Completes Patient Enrollment in Phase 3 NATiV3 Trial for MASH Treatment

Inventiva ("Inventiva" or the "Company"), a clinical-focused biopharmaceutical company focused on the development of orally administered small molecule dru...

April 02, 2025 | Wednesday | News
FDA Approves Freeze-Dried Formulation of JYNNEOS® for Smallpox and Mpox Prevention

Bavarian Nordic A/S announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS® (Smallpox and...

April 01, 2025 | Tuesday | News
Merck Exercises Global Commercialization Option for Pimicotinib, Marking a Milestone in Partnership with Abbisko Therapeutics

Abbisko Therapeutics Co., Ltd. announced that Merck has exercised the global commercialization option for pimicotinib (ABSK021), with an option exercise fe...

April 01, 2025 | Tuesday | News
Alnylam Presents New Data from HELIOS-B Trial at ACC.25, Highlighting Vutrisiran’s Impact on ATTR-CM Treatment

Alnylam Pharmaceuticals, Inc. , the leading RNAi therapeutics company, announced moderated poster presentations of new data from the landmark HELIOS-B...

March 31, 2025 | Monday | News
Regeneron and Sanofi Receive Approval for Dupixent® in Japan to Treat Chronic Obstructive Pulmonary Disease (COPD)

TARRYTOWN -- Regeneron Pharmaceuticals, and Sanofi announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan ...

March 31, 2025 | Monday | News
CHMP Recommends Opdivo® for EU Approval as Neoadjuvant and Adjuvant Treatment for Resectable NSCLC

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a...

March 31, 2025 | Monday | News
AstraZeneca’s Calquence® Combination Therapy Recommended for EU Approval in Untreated Mantle Cell Lymphoma

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Un...

March 31, 2025 | Monday | News
Novartis Announces FDA Approval for Expanded Use of Pluvicto® in mCRPC, Tripling Eligible Patient Access

Novartis announced that the US Food and Drug Administration (FDA) approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) for patients with pro...

March 31, 2025 | Monday | News
Medtronic’s Evolut TAVR Demonstrates Durable Outcomes at Five Years in Low-Risk Patients with Severe Aortic Stenosis

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. D...

March 31, 2025 | Monday | News

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