Agios Pharmaceuticals Receives CHMP Positive Opinion for PYRUKYND® in Treating Alpha- and Beta-Thalassemia

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rar...

October 20, 2025 | Monday | News
Kezar Life Sciences Initiates Strategic Review Following FDA Setback on Autoimmune Hepatitis Trial

-Kezar Life Sciences, Inc. a clinical-stage biotechnology company developing novel small molecule therapeutics to treat unmet needs in immune-mediated di...

October 17, 2025 | Friday | News
China NMPA Accepts Belite Bio’s NDA for Tinlarebant with Priority Review Based on Phase 3 DRAGON Interim Data

NMPA’s response is based on the Phase 3 DRAGON interim analysis results Topline final data expected in Q4 2025  Belite Bio, Inc. (NASDAQ...

October 16, 2025 | Thursday | News
Qualio Introduces AI-Powered Compliance Intelligence to Redefine Life Sciences Regulatory Management

AI-powered gap analysis, continuous compliance monitoring, real-time visibility, and pre-built life sciences frameworks help organizations reduce audit p...

October 15, 2025 | Wednesday | News
Zenas BioPharma Secures Global Rights to Orelabrutinib, Expands Pipeline with Novel IL-17AA/AF and TYK2 Inhibitors

Zenas BioPharma, Inc. (“Zenas,” “Zenas BioPharma” or the “Company”) (Nasdaq: ZBIO) and InnoCare Pharma Limited (&ldqu...

October 09, 2025 | Thursday | News
Neurona Therapeutics Treats First Non-MTS Subject in Phase 1/2 Trial of NRTX-1001 for Drug-Resistant Temporal Lobe Epilepsy

  - First subject received unilateral administration of NRTX-1001 in a new non-MTS cohort; no significant surgical complications or adverse events re...

October 09, 2025 | Thursday | News
Invivyd Receives FDA Clearance to Advance REVOLUTION Program with Phase 3 DECLARATION and LIBERTY Trials for COVID Prevention

The DECLARATION (safety and efficacy vs. placebo) and LIBERTY (exploratory safety head-to-head and combination with mRNA-based COVID vaccination) clini...

October 07, 2025 | Tuesday | News
Advanz Pharma and Alvotech Secure EMA Acceptance for Xolair® Biosimilar AVT23

Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospita...

October 07, 2025 | Tuesday | News
KARL STORZ Receives FDA Clearance for ENDOFLATOR™ +, the Next Generation in Surgical Insufflation and Smoke Evacuation

KARL STORZ, a global leader in minimally invasive surgical technology, is proud to announce it has received U.S. Food and Drug Administration (FDA) clear...

October 06, 2025 | Monday | News
Avobis Bio Earns FDA RMAT Designation for AVB-114 in Crohn’s Perianal Fistulas

Avobis Bio LLC, a clinical-stage company developing implantable cell therapies, announced  that the U.S. Food and Drug Administration ("FDA") has gr...

October 06, 2025 | Monday | News
George Medicines and Biolab Partner to Bring Innovative Hypertension Therapy GMRx2 to Brazil

Biolab Farmacêutica gains exclusive rights in Brazil to GMRx2, an innovative single pill combination of three medicines, including two doses that...

October 03, 2025 | Friday | News
Barinthus Bio and Clywedog Therapeutics Announce Definitive Merger Agreement to Create Nasdaq-Listed Clywedog Therapeutics, Inc.

The combined company, Clywedog Therapeutics, will bring a portfolio that includes three differentiated, clinical stage product candidates which are bei...

October 01, 2025 | Wednesday | News
Trump Prescribes a 100% Tariff: Because Nothing Says “Affordable Healthcare” Like Doubling the Price of Pills

US President Donald Trump has announced a 100% import tariff on all branded or patented pharmaceutical products, effective 1 October. The steep duty will d...

September 28, 2025 | Sunday | Analysis
European Commission Approves Lilly’s Kisunla™ (donanemab) for Early Symptomatic Alzheimer’s Disease

Approved for use in the earliest symptomatic stages, Kisunla is the only once-monthly amyloid plaque–targeting therapy with evidence supporting tre...

September 26, 2025 | Friday | News

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