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
Eton Pharmaceuticals Secures FDA Approval for KHINDIVI™, the First Oral Liquid Hydrocortisone for Pediatric Adrenal Insufficiency

Eton Pharmaceuticals, Inc (“Eton” or “the Company”) (Nasdaq: ETON), an innovative pharmaceutical company focused on developing an...

May 29, 2025 | Thursday | News
Johnson & Johnson’s DARZALEX FASPRO® Receives ODAC Support for High-Risk Smoldering Multiple Myeloma

ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study If approved, DARZALEX FASPRO® w...

May 21, 2025 | Wednesday | News
Bayer Secures FDA Approval to Expand Jivi® Use in Children With Hemophilia A

-Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi®, a recombinant DNA-derived, extended half-life factor VIII conce...

May 20, 2025 | Tuesday | News
FDA Commissioner Martin A. Makary Ends Double Standard, Expands Unannounced Inspections at Foreign Manufacturing Sites

  U.S. Food and Drug Administration announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produc...

May 20, 2025 | Tuesday | News
Invivyd Urges FDA to Modernize COVID-19 Vaccine Evaluation Through Citizen Petition

Invivyd, Inc. announced it has submitted a Citizen Petition with the U.S. Food and Drug Administration (FDA) calling on the Agency to evolve from histori...

May 15, 2025 | Thursday | News
UTR Therapeutics Files IND with FDA for UTRxM1-18 to Target c-MYC Driven Cancers with Ultra-Precise RNA Degradation

UTR Therapeutics Inc (UTRx Inc.), a drug development biotech company based in New York City, USA is pleased to announce a new milestone, the submission o...

May 12, 2025 | Monday | News
Shuttle Pharma Nears 50% Enrollment in Phase 2 Trial of Ropidoxuridine for Glioblastoma with Promising Tolerability and Completion Rates

Shuttle Pharmaceuticals Holdings, Inc. , a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer pati...

May 09, 2025 | Friday | News
Australia’s Immutep Achieves 17.6-Month Survival with Chemo-Free Immunotherapy in Head and Neck Cancer

Complementary nature of these two immunotherapies leads to excellent 17.6-month median Overall Survival in head and neck cancer patients with PD-L1 CPS...

May 06, 2025 | Tuesday | News
Teva and Alvotech’s SELARSDI™ Approved by FDA as Interchangeable Biosimilar to Stelara®

The U.S. FDA has approved SELARSDI™ (ustekinumab-aekn) as interchangeable with the reference biologic Stelara® (ustekinumab) in all presentat...

May 06, 2025 | Tuesday | News
Rising IgA Nephropathy Cases Drive Demand for Innovative Treatments as Targeted Therapies Gain Ground

IgA nephropathy (IgAN) is an autoimmune disorder that affects the kidneys by impairing the filtration function of the small blood vessels. It is caused by ...

April 29, 2025 | Tuesday | News
ImmVira Presents Promising Phase I Results for Oncolytic HSV Therapy MVR-C5252 in Recurrent Malignant Glioma at AACR 2025

From April 25 to April 30, 2025, U.S. time, ImmVira presented the Phase I clinical results of its oncolytic Herpes Simplex Virus ("oHSV") product MVR-...

April 28, 2025 | Monday | News
Ascletis Reports Positive Phase Ib Results for Oral GLP-1R Agonist ASC30 in Obesity, Supporting Phase IIa Advancement

 Ascletis Pharma Inc.  announces  positive topline results of its randomized, double-blind, placebo-controlled Phase Ib multiple ascending d...

April 23, 2025 | Wednesday | News
Regeneron Expands U.S. Manufacturing with $3B+ Fujifilm Partnership to Boost Biologics Capacity

Regeneron Pharmaceuticals, Inc.  announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotec...

April 23, 2025 | Wednesday | News

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