Genentech’s Gazyva® Receives FDA Approval for the Treatment of Lupus Nephritis in Adults

 The U.S. Food and Drug Administration (FDA) has approved Gazyva® (obinutuzumab), developed by Genentech, as a treatment for adults with lupus n...

October 21, 2025 | Tuesday | News
Adcytherix Raises €105 Million Series A to Advance Next-Generation Antibody–Drug Conjugates with Novel Payloads

Adcytherix Raises EUR 105M Series A to Accelerate Breakthrough Antibody-Drug Conjugate Pipeline with Strategic Focus on Novel Payloads Financing led b...

October 20, 2025 | Monday | News
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
Building Biopharma Resilience — Cytiva’s Pierre-Alain Ruffieux on Balancing Progress and Preparedness

Resilience is no longer a corporate slogan — it’s the new currency of survival in biopharma. As the sector races between scientific breakthroug...

October 20, 2025 | Monday | Interaction
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
Thermo Fisher and OpenAI Unite to Accelerate Drug Development with Frontier AI

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, announced plans to further increase the impact of Thermo Fisher’s p...

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
SCYNEXIS to Receive $22 Million from GSK as Phase 3 MARIO Study on Invasive Candidiasis Is Terminated

SCYNEXIS to receive a $22 million payment as part of the resolution related to the restart of the Phase 3 MARIO study on invasive candidiasis Scynexis...

October 16, 2025 | Thursday | Regulatory
Quotient Sciences and Biorasi Partner to Streamline Early Clinical Trials from IND to Proof-of-Concept

Quotient Sciences, a leading global drug development, research and manufacturing accelerator, and Biorasi, a global clinical research organization (CRO),...

October 15, 2025 | Wednesday | News
Nasus Pharma Partners with Aptar to Advance Intranasal Epinephrine NS002 Toward Commercialization

Nasus Pharma Ltd. (NYSE: NSRX) (“Nasus Pharma” or the “Company”), a clinical-stage pharmaceutical company focused on the developm...

October 13, 2025 | Monday | News
Roquette Unveils Novel Excipient KLEPTOSE® Crysmeb to Advance Drug Solubility and Delivery Performance

Roquette, a global leader in plant-based ingredients and pharmaceutical excipients for the health and nutrition sectors, today, celebrates the launch of ...

October 09, 2025 | Thursday | 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
Esperion Secures Key Patent Settlement with Dr. Reddy’s, Protecting NEXLETOL and NEXLIZET Until 2040

Esperion announced that it has entered into a settlement agreement with Dr. Reddy’s Laboratories, Inc. and its affiliate Dr. Reddy’s Laborato...

October 06, 2025 | Monday | News
Sitryx Therapeutics Receives FDA Clearance to Advance SYX-5219 Into Phase 1b Trial for Atopic Dermatitis

SYX-5219 is a first-in-class oral PKM2 modulator designed to drive sustained disease remission across a range of autoimmune diseases Phase 1b trial to...

October 03, 2025 | Friday | News

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