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
Azurity Pharmaceuticals Receives FDA Approval for Ferabright™, the First Iron-Based MRI Contrast Agent for Brain Tumour Imaging

Azurity Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved FerabrightTM (ferumoxytol injection), the first and...

October 20, 2025 | Monday | 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
Excellergy Launches with $70M Series A to Redefine Allergy Treatment with First-in-Class Trifunctional ECRIs

-Redefining Allergy Treatment with New Class of Trifunctional ECRIs designed to deliver powerful efficacy, rapid relief and complete control of alle...

October 14, 2025 | Tuesday | 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
Rein Therapeutics Receives EMA Approval to Launch Phase 2 RENEW Trial of LTI-03 in Germany and Poland

EMA approval covers study sites in Germany and Poland as part of the Company’s global Phase 2 RENEW trial Trial will evaluate LTI-03, a first-in...

October 13, 2025 | Monday | 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
ME Therapeutics Secures U.S. Patent for Lead G-CSF Antibody Candidate to Advance Cancer Immunotherapies

ME Therapeutics Holdings Inc. a publicly listed biotechnology company working on novel cancer fighting drugs in the field of immuno-oncology, is pleased ...

September 29, 2025 | Monday | News
Eisai and Biogen Gain Australian Approval for LEQEMBI® in Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. announced that the Therapeutic Goods Administration (TGA) of Australia has approved LEQEMBI® (lecanemab), a humanized...

September 25, 2025 | Thursday | News
Ncardia Launches First iPSC-Derived Non-Human Primate Cardiomyocytes for Translational Cardiac Research

-Ncardia, a leader in stem cell–based solutions for drug discovery and safety assessment,  announced the launch of Ncyte® NHP-C vCardiomyo...

September 24, 2025 | Wednesday | News
Illumina Expands Global CDx Partnerships to Advance KRAS-Targeted Precision Oncology

Illumina Inc. (NASDAQ: ILMN) will partner with multiple global pharmaceutical companies to develop companion diagnostics (CDx) enabled on the T...

September 24, 2025 | Wednesday | News
Angelini Pharma and South Korea’s Sovargen Sign Global Option Agreement for First-in-Class Brain Health Therapy SVG105

Angelini Pharma, part of the privately owned Angelini Industries, and Sovargen, a South-Korean biotechnology company, announced today that they signed an...

September 23, 2025 | Tuesday | News
Esperion and Otsuka Secure MHLW Approval for NEXLETOL® in Japan to Treat Hypercholesterolemia

Esperion announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka), the Company’s partner for the development and commercialization of NEXLETOL® ...

September 22, 2025 | Monday | News

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