News and Press Releases
Iksuda Therapeutics receives FDA IND clearance for IKS014
FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore Preliminary data from an ongoing dose-escalation study of IKS014 has shown meaningful clinical activity across...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: July 1, 2025
argenx Announces European Commission Approval of VYVGART Subcutaneous Injection for Chronic Inflammatory Demyelinating Polyneuropathy
VYVGART® SC, first-and-only IgG Fc-antibody fragment which specifically targets the neonatal Fc receptor (FcRn), now approved for use in Europe for CIDP Approval based on ADHERE clinical trial, the largest...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: June 20, 2025
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SolasCure receives FDA Fast Track Designation for Aurase Wound Gel to treat calciphylaxis ulcers
Recognises the potential of Aurase Wound Gel to improve outcomes for individuals with calciphylaxis ulcers, a rare and life-threatening condition Represents a new indication for Aurase Wound Gel, currently in...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 16, 2025
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
European Commission approves subcutaneous RYBREVANT▼ (amivantamab) for the treatment of patients with advanced EGFR-mutated non-small cell lung cancer
Subcutaneous (SC) amivantamab offers patients greater convenience, reducing administration time from hours to minutes and with a five-fold reduction in infusion-related reactions compared to the IV formulation European Commission (EC) approval based on positive...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 7, 2025
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Rilzabrutinib granted orphan drug designation in the US for two rare diseases with no approved medicines
Designation granted for warm autoimmune hemolytic anemia and IgG4-related disease Rilzabrutinib is currently under regulatory review in the US, EU and China for potential use in immune thrombocytopenia. 3 April...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 3, 2025
Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older
Brexpiprazole’s indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older Approval follows a positive Committee for Medicinal Products for Human Use...
Category: Drug Discovery, Other, Pharmaceutical
Posted: March 13, 2025
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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
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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
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
PacBio and Radboud UMC Announce Remarkable Study Results Using HiFi Long Read Sequencing to Help Advance Rare Disease Diagnostics
14 January 2025 – Menlo Park, California US – PacBio (NASDAQ: PACB), a leading provider of highly accurate long-read sequencing solutions, announced a significant publication from Radboud University Medical Center...
Category:
Posted: January 16, 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
