Samsung Biologics Secures Court Injunction to Maintain Production During Industrial Action

Samsung Biologics (KRX: 207940.KS) confirmed that the Seoul High Court has ruled in the company's favor, granting an injunction prohibiting industrial acti...

October 20, 2026 | Tuesday | News
Daiichi Sankyo and Merck Withdraw U.S. BLA for Ifinatamab Deruxtecan in Small Cell Lung Cancer

The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as M...

September 28, 2026 | Monday | News
Pharming Seeks FDA Approval to Expand Joenja Use to Younger Children With APDS

If approved, Joenja would be available to eligible patients aged 4 years and older with APDS who weigh 13 kg or more Decision follows recent approval ...

September 28, 2026 | Monday | News
Altruist Biologics Suzhou Facility Passes EMA GMP Inspection with Zero Critical Findings

Altruist Biologics, a world-class contract development and manufacturing organization (CDMO) and wholly owned subsidiary of Innovent Biologics (1801.HK), a...

September 24, 2026 | Thursday | News
Andelyn Biosciences Begins Commercial Manufacturing of FDA-Approved Fayuvi Gene Therapy

Andelyn Biosciences (“Andelyn”), a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (&ldqu...

September 23, 2026 | Wednesday | News
Lōkahi Therapeutics and University of Alabama Extend Biopharma Asset Evaluation Collaboration

Lōkahi Therapeutics, a subsidiary of Glucotrack, Inc., announced that The University of Alabama’s Culverhouse College of Business will continue it...

September 22, 2026 | Tuesday | News
XORTX Therapeutics Targets Q4 2026 FDA IND Submission for XRx-026 Gout Program

XORTX Therapeutics Inc. (“XORTX” or the “Company”), a late-stage clinical pharmaceutical company focused on developing innov...

September 21, 2026 | Monday | News
Flow Neuroscience Launches FDA-Approved FL-100 At-Home tDCS Treatment in the US

Flow Neuroscience announced that FL-100 is now available by prescription across the United States, introducing the first FDA-approved at-home transc...

September 18, 2026 | Friday | News
Boehringer Ingelheim Launches PED Essentials to Strengthen Patient Experience Data

Ingelheim, Germany - Boehringer Ingelheim announced the launch of PED Essentials, a comprehensive e-learning hub designed to help patient organizations g...

September 18, 2026 | Friday | News
MaaT Pharma Faces Negative CHMP Trend for MaaT013 aGvHD Application

MaaT Pharma was informed of a negative trend during the Committee for Medicinal Products for Human Use (CHMP)’s Oral Explanation meeting which ...

September 16, 2026 | Wednesday | News
Elixir Medical Secures Japan Approval for DynamX Sirolimus-Eluting Coronary Bioadaptor System

Elixir Medical (Milpitas, Calif., and Tokyo) announced that its DynamX® Sirolimus-Eluting Coronary Bioadaptor System for the treatment of cor...

September 16, 2026 | Wednesday | News
XORTX Begins GMP Drug Substance and Tablet Manufacturing for XORLO™

Contract manufacturing of GMP drug substance and commercial-scale tablets to support the XRX-OXY-102 clinical study and future US FDA marketing approval...

September 14, 2026 | Monday | News
Omniscient Gains FDA 510(k) Clearance for Quicktome Deep Brain DBS Workflow

Omniscient announced 510(k) clearance from the U.S. Food and Drug Administration for a new workflow within the Quicktome® platform: Quicktome Deep Br...

September 14, 2026 | Monday | News
FDA Grants Priority Review to Genentech’s Enspryng for Rare Autoimmune Disease MOGAD

If approved, Enspryng would be the first and only disease-modifying therapy for MOGAD (myelin oligodendrocyte glycoprotein antibody-associated diseas...

September 11, 2026 | Friday | News

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