Ascletis Reports Positive Phase Ib Results for Oral GLP-1R Agonist ASC30 in Obesity, Supporting Phase IIa Advancement

 Ascletis Pharma Inc.  announces  positive topline results of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending d...

April 23, 2025 | Wednesday | News
Regeneron Expands U.S. Manufacturing with $3B+ Fujifilm Partnership to Boost Biologics Capacity

Regeneron Pharmaceuticals, Inc.  announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotec...

April 23, 2025 | Wednesday | News
Dupixent Secures FDA Nod for Chronic Spontaneous Urticaria in Patients Unresponsive to Antihistamines

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,0...

April 21, 2025 | Monday | News
Daiichi Sankyo and AstraZeneca’s ENHERTU Combo Outperforms Standard of Care in First-Line HER2+ Metastatic Breast Cancer

DESTINY-Breast09 phase 3 trial of Daiichi Sankyo and AstraZeneca’s ENHERTU is the first trial in more than a decade to demonstrate superior eff...

April 21, 2025 | Monday | News
FDA Rejects Regeneron’s Bid for Extended Dosing of EYLEA HD® Beyond 16 Weeks

Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding ...

April 21, 2025 | Monday | News
Pfizer Applauds CDC Panel’s Expanded Recommendation for RSV Vaccination in At-Risk Adults Aged 50–59

Pfizer Inc. announced  that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) vote...

April 17, 2025 | Thursday | News
Celltrion’s YUFLYMA® Granted FDA Interchangeable Biosimilar Status to Humira®

Celltrion, Inc. announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab-aaty), as an interchangeable biosim...

April 15, 2025 | Tuesday | News
INVO Fertility Rebrands and Refocuses on Fertility Services, Separates Oncology Operations

INVO Fertility, Inc., formerly known as NAYA Biosciences, Inc., a healthcare services fertility company focused on expanding access to advanced treatment t...

April 15, 2025 | Tuesday | News
FDA Clears argenx SE’s VYVGART Hytrulo Prefilled Syringe for Patient Self-Injection

argenx SE, a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, announced that the U.S. Food a...

April 11, 2025 | Friday | News
FDA Approves Opdivo® Plus Yervoy® as First-Line Treatment for MSI-H/dMMR Metastatic Colorectal Cancer

 Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy®...

April 10, 2025 | Thursday | News
Shilpa Pharma Lifesciences Passes Second Consecutive FDA Inspection with No Observations

Shilpa Medicare announces that Shilpa Pharma Lifesciences – a wholly owned subsidiary – has successfully passed a U.S. Food and Drug Admin...

April 10, 2025 | Thursday | News
Science 37 Achieves Second Successful FDA Inspection, Reaffirming Commitment to High-Quality Clinical Trials

Science 37, a leader in enhancing patient access to clinical trials, announced the successful completion of its second FDA inspection, reaffirming the qual...

April 10, 2025 | Thursday | News
CareMed Joins Limited Distribution Network for Vanrafia™ (Atrasentan) in Treatment of Primary IgAN

CareMed, an independent specialty pharmacy, is in the Limited Distribution Network for Vanrafia™ (atrasentan), for the reduction of proteinuria ...

April 08, 2025 | Tuesday | News
AVITA Medical Launches Cohealyx™ in the U.S., Expanding Portfolio for Transformative Acute Wound Care

AVITA Medical, Inc., a leading therapeutic acute wound care company delivering transformative solutions, announced the U.S. commercial launch of Cohealyx&t...

April 07, 2025 | Monday | News

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