The Challenge of Modern Drug Discovery

Enter Generative AI: A Paradigm Shift Today, generative AI is changing this equation. Unlike traditional AI that analyzes existing data, generative AI can...

June 03, 2025 | Tuesday | Expert Opinion
Roche’s Itovebi™ Regimen Cuts Risk of Death by Over 30% in PIK3CA-Mutated HR+ Advanced Breast Cancer

The ItovebiTM (inavolisib)-based regimen reduced the risk of death by more than 30% in people with PIK3CA-mutated HR-positive, HER2-negative advanced b...

June 02, 2025 | Monday | News
Kura Oncology’s NDA for Ziftomenib in NPM1-Mutant AML Accepted by FDA with Priority Review

Kura Oncology, Inc.  announced the U.S. Food and Drug Administration (FDA) has accepted Kura’s New Drug Application (NDA) seeking full approva...

June 02, 2025 | Monday | News
Alzamend Doses First Patient in Phase II Trial of AL001, Aiming to Transform Lithium Therapy for Neurological Disorders

Topline data expected by year end Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithi...

May 30, 2025 | Friday | News
Candel Therapeutics Secures FDA RMAT Designation for CAN-2409 in Localized Prostate Cancer

Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological ...

May 29, 2025 | Thursday | News
SCYNEXIS Resumes Dosing in Phase 3 MARIO Study for Invasive Candidiasis Following FDA Clinical Hold Lift

SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infe...

May 29, 2025 | Thursday | News
Why CPOs are vital to getting medical trials over the line

While studies to test the safety and efficacy of new drugs are necessary, their success cannot be guaranteed. In fact, it’s likely that at least 80...

May 28, 2025 | Wednesday | News
Augustine Therapeutics Doses First Patient in Phase I Trial of Novel HDAC6 Inhibitor for Charcot-Marie-Tooth Disease

Augustine Therapeutics NV (“Augustine” or “the Company”), a biotechnology company focused on developing new therapies for neuromu...

May 28, 2025 | Wednesday | News
GlycoEra Secures $130M Series B to Advance First-in-Class IgG4 Protein Degrader Into Clinical Trials

Financing led by Novo Holdings with significant support from world-class group of existing and new investors Proceeds from financing to support developm...

May 28, 2025 | Wednesday | News
Endurance Bio’s T-168 Selected for SLEIPNIR Trial Platform in Parkinson’s Disease

Endurance Bio Inc., a clinical-stage biotechnology company developing therapies for neurodegenerative and metabolic diseases, today announced that its co...

May 26, 2025 | Monday | News
Invivyd’s PEMGARDA® Added to NCCN Guidelines for B-Cell Lymphomas Amid Ongoing COVID-19 Risk

Invivyd, Inc. announced that PEMGARDA® (pemivibart), its investigational monoclonal antibody, has been added to the National Comprehensive Cancer Net...

May 26, 2025 | Monday | News
Roche’s Itovebi™ Receives Positive CHMP Opinion for First-Line Treatment of PIK3CA-Mutated Advanced Breast Cancer

Positive recommendation based on phase III INAVO120 data showing ItovebiTM (inavolisib) in combination with palbociclib and fulvestrant more than doubl...

May 26, 2025 | Monday | News
AnnJi’s AJ201 Shows Positive Clinical Signals in Phase 1/2a Trial for Rare Neuromuscular Disease SBMA

AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, and...

May 23, 2025 | Friday | News
Astellas and Pfizer’s XTANDI Demonstrates 30% Reduced Risk of Death at Five Years in mHSPC Patients

Astellas Pharma Inc. (TSE: 4503) and Pfizer Inc. (NYSE: PFE)  announced compelling five-year overall survival (OS) results from the open-label exten...

May 23, 2025 | Friday | News

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