News and Press Releases
Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults
In laboratory studies, zoliflodacin has been shown to be active against Neisseria gonorrhoeae including multidrug-resistant strains If approved, zoliflodacin could become the first new antibiotic treatment for gonorrhea in decades. 10 June...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 10, 2025
Johnson & Johnson submits application to the European Medicines Agency for additional subcutaneous RYBREVANT▼(amivantamab) dosing regimens to treat patients with EGFR-mutated advanced non-small cell lung cancer
Application supports every-three-week (Q3W) and every-four-week (Q4W) SC amivantamab dosing regimens Subcutaneous (SC) amivantamab offers patients greater convenience with reduced administration time from hours to minutes and lower rates of...
Category: Drug Discovery, Other, Pharmaceutical
Posted: May 6, 2025
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
FDA Grants OKYO Pharma Fast Track Designation to Urcosimod for Neuropathic Corneal Pain
1 May 2025 -- London, UK and New York, US -- OKYO Pharma Limited, an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 1, 2025
Fondazione Telethon Submits US Biological License Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Sydrome
11 March 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Biologics License Application (BLA) for the...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 11, 2025
OKYO Pharma Files for Fast Track Designation with FDA for Urcosimod to Treat Neuropathic Corneal Pain
10 March 2025 -- London, UK and New York, US -- OKYO Pharma Limited, a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain, a severe...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 10, 2025
Bioxodes obtains Orphan Drug Designation for hemorrhagic stroke therapeutic candidate in US and Europe
FDA, EMA grant BIOX-101 ODD status to treat intracerebral hemorrhagic stroke (ICH) ODD status may expedite drug candidate development and approvals BIOX-101 interim Phase 2a data in ICH imminent. 5...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 5, 2025
Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
4 March 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 4, 2025
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis
Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025
CHMP recommends subcutaneous RYBREVANT®▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Data from the Phase 3 PALOMA-3 study showed non-inferiority to intravenous administration meeting both co-primary pharmacokinetic (PK) endpoints, as well as a five-fold reduction in infusion-related reactions and fewer venous...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 3, 2025
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Opella reaches study milestone for Cialis
21 January 2025 -- Paris, France -- Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual...
Category: Clinical Trials, Other, Pharmaceutical
Posted: January 21, 2025
HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval. 14 January 2025 -- Hong Kong, Shanghai, and New Jersey, US --...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2025
PureTech Receives FDA Fast Track Designation for LYT-200 in Acute Myeloid Leukemia (AML)
Single agent and combination data from Phase 1b AML/MDS trial presented at ASH 2024 showed potential of LYT-200 to serve broad range of patients across various lines of treatment LYT-200...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 9, 2025
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
1 October 2024 -- New Jersey, US -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: October 1, 2024
PTC Therapeutics Inc. 100 Corporate Court South Plainfield, NJ 07080-2449
PureTech-Invented KarXT Receives U.S. Food and Drug Administration Approval for the Treatment of Schizophrenia in Adults
Milestone triggers payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb in March 2024, and...
Category: Other, Pharmaceutical
Posted: September 27, 2024
Duke Street Bio Granted Approval by European Medicines Agency to Launch Next-Generation PARP1-Selective Inhibitor Trial
24 September 2024 -- London, UK -- Duke Street Bio Ltd, a precision medicine biotech developing next generation small molecule cancer therapies, is pleased to announce that the European Medicines...
Category: Clinical Trials, Drug Discovery, Pharmaceutical
Posted: September 24, 2024
