Regulatory

FDA Rejects Genentech’s Bid to Expand Use of Lymphoma Drug Columvi

By Athulya B S
20 July 2025

Genentech, a member of the Roche Group, announced Friday that the U.S. Food and Drug Administration (FDA) has rejected its application to expand the use of its cancer drug Columvi® (glofitamab-gxbm). The FDA issued a Complete Response Letter (CRL) for the supplemental Biologics License Application (sBLA), effectively declining to approve Columvi in combination with chemotherapy for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Regulatory Approval News Vaccines

U.S. FDA Approves Convenient Prefilled Syringe for GSK’s Shingles Vaccine, Shingrix

By Ajmal Aseem
17 July 2025

The U.S. Food and Drug Administration (FDA) has given the green light to a new, prefilled syringe presentation of GSK’s highly effective shingles vaccine, Shingrix.

Regulatory Healthcare & Pharmaceuticals News Vaccines

FDA to Review GSK’s Arexvy RSV Vaccine for Expanded Use in At-Risk Adults Aged 18-49

By Athulya B S
14 July 2025

An application from GSK to increase the use of its very effective RSV vaccine, Arexvy, has been formally approved by the U.S. Food and Drug [Read More…]

Regulatory Approval News

FDA Approves Updated Label for Lilly’s Alzheimer’s Drug Kisunla (donanemab-azbt), Offering a Safer Dosing Schedule

By Ajmal Aseem
10 July 2025

The U.S. Food and Drug Administration (FDA) has officially approved an updated label for Eli Lilly’s groundbreaking Alzheimer’s drug, Kisunla (donanemab-azbt). This significant update introduces a new, more gradual dosing schedule specifically designed to enhance patient safety by reducing the risk of amyloid-related imaging abnormalities (ARIA), a critical side effect.

Regulatory Healthcare & Pharmaceuticals News Weight-loss Drugs

Novo Nordisk Seeks EU Approval for Higher Dose of Wegovy®, Promising Greater Weight Loss

By Athulya B S
9 July 2025

Novo Nordisk has applied to the European Medicines Agency (EMA) for a new, increased dosage of Wegovy® (semaglutide), a well-known medication for weight loss, of [Read More…]

Regulatory Approval Healthcare & Pharmaceuticals News

AstraZeneca’s Imfinzi Gains EU Approval as First Perioperative Immunotherapy for High-Risk Bladder Cancer

By Athulya B S
4 July 2025

The European Commission has approved AstraZeneca’s Imfinzi, establishing a new standard of care for muscle-invasive bladder cancer. This landmark decision makes Imfinzi the first perioperative immunotherapy available to patients in the EU, following a pivotal Phase III trial where the regimen significantly reduced the risk of cancer recurrence and death. This approval marks a transformative moment for patients with this high-risk disease.

Regulatory Healthcare & Pharmaceuticals Neuroscience

U.S. FDA Approves Updated Label for Lilly’s Amyvid, Expanding its Role in Alzheimer’s Diagnosis and Treatment

By Ajmal Aseem
26 June 2025

A significant step in Alzheimer’s care: The FDA’s updated approval for the Amyvid PET scan allows for better diagnosis and patient selection for the latest amyloid-based treatments

Regulatory Approval News Oncology

AstraZeneca’s Datroway Receives US Approval for EGFR-Mutated Lung Cancer

By Ajmal Aseem
25 June 2025

AstraZeneca’s Datroway has received US FDA approval for advanced EGFR-mutated lung cancer. This first-in-class TROP2-directed therapy offers a vital new option for patients who have exhausted previous treatments.

Weight-loss Drugs News Regulatory

Novo Nordisk’s Ozempic® Gains EU Recommendation for Peripheral Arterial Disease (PAD)

By Athulya B S
24 June 2025

Novo Nordisk announced that its leading diabetes medication, Ozempic® (semaglutide), has received a positive recommendation in the EU for an updated label to include peripheral arterial disease.

Regulatory Approval

FDA Approves Sanofi’s Dupixent (dupilumab) as First and Only Targeted Medicine for Bullous Pemphigoid in the U.S.

By Ajmal Aseem
21 June 2025

The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as the first and only targeted biologic treatment for adults with bullous pemphigoid, a rare and debilitating autoimmune skin disease.

Category: Regulatory

FDA Rejects Genentech’s Bid to Expand Use of Lymphoma Drug Columvi

U.S. FDA Approves Convenient Prefilled Syringe for GSK’s Shingles Vaccine, Shingrix

FDA to Review GSK’s Arexvy RSV Vaccine for Expanded Use in At-Risk Adults Aged 18-49

FDA Approves Updated Label for Lilly’s Alzheimer’s Drug Kisunla (donanemab-azbt), Offering a Safer Dosing Schedule

Novo Nordisk Seeks EU Approval for Higher Dose of Wegovy®, Promising Greater Weight Loss

AstraZeneca’s Imfinzi Gains EU Approval as First Perioperative Immunotherapy for High-Risk Bladder Cancer

U.S. FDA Approves Updated Label for Lilly’s Amyvid, Expanding its Role in Alzheimer’s Diagnosis and Treatment

AstraZeneca’s Datroway Receives US Approval for EGFR-Mutated Lung Cancer

Novo Nordisk’s Ozempic® Gains EU Recommendation for Peripheral Arterial Disease (PAD)

FDA Approves Sanofi’s Dupixent (dupilumab) as First and Only Targeted Medicine for Bullous Pemphigoid in the U.S.

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