Genentech’s Fenebrutinib Receives FDA Priority Review for Relapsing and Progressive Multiple Sclerosis

Fenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in dela...

October 01, 2026 | Thursday | News
Vanda Reports Positive Phase III Results for HETLIOZ in Delayed Sleep-Wake Phase Disorder

Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced positive topline results from its pivotal Phase III study of HETLIOZ® (tasimelteon) 20 mg in a...

October 01, 2026 | Thursday | News
QIAGEN Expands US QIAstat-Dx Bloodstream Infection Testing with New FDA-Cleared Panel

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced that U.S. laboratories now have access to the complete QIAstat-Dx bloodstream infection p...

September 29, 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
Elevar Therapeutics Receives FDA Approval for Lyrfigtu in FGFR2-Altered Bile Duct Cancer

Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment...

September 25, 2026 | Friday | 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
FDA Approves AQNEURSA as First Treatment for Ataxia-Telangiectasia

IntraBio Inc., a leader in the discovery, development, and commercialization of novel therapies for rare and common neurodegenerative diseases, announced...

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
Amneal Launches FDA-Approved Lanreotide Injection to Expand Complex Injectable Portfolio

Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) announced that the U.S. Food and Drug Administration (FDA) has approved ...

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
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

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