Pharmafile Logo

News and Press Releases

Heidelberg Pharma’s Lead ADC Candidate HDP-101 Granted Fast Track Designation by US FDA for the Treatment of Multiple Myeloma

Recognizes the potential of HDP-101 to address a serious or life-threatening condition with high unmet medical needs Enables more frequent engagement with FDA and eligibility for rolling review to support...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 23, 2025

Heidelberg Pharma
info@hdpharma.com
Gregor-Mendel-Straße 22 68526 Ladenburg Deutschland

SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting

20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025

SOM Biotech
Baldiri Reixac, 4 (08028) Barcelona, Spain

Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years

If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from...

Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 1, 2025

Pharming Group NV
info@pharming.com
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands

Sanofi’s SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration

Designation earned for a one-time intravitreal gene therapy with the potential to eliminate treatment burden for people living with neovascular age-related macular degeneration Neovascular or “wet” age-related macular degeneration can...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: September 11, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

PulseSight Therapeutics Provides New Insights into the Role of Iron and Transferrin in AMD, Supporting its PST-611 Vectorized Therapy for Dry AMD/Geographic Atrophy at EURETINA 2025

4 September 2025 -- Paris, France -- PulseSight Therapeutics, an ophthalmology biotech company developing disruptive non-viral vectorized therapies with minimally-invasive delivery technology announces that its CSO, Thierry Bordet Ph.D., will...

Category: Clinical Trials, Drug Delivery, Drug Discovery, Other, Pharmaceutical
Posted: September 4, 2025

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

Iksuda
The Biosphere, Draymans Way, Newcastle Helix Newcastle upon Tyne NE4 5BX

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

SolasCure
wellington house East Rd, Petersfield, Cambridge CB1 1BH

New Anthem from Girl Band Raises Awareness of Type1 Diabetes After Research Highlights Silent Struggle

Recent research from Sanofi highlights the significant impact of Type 1 Diabetes on those living with the condition The song, “Rise Up,” shares their experiences of living with the condition...

Category: Other, Pharmaceutical
Posted: May 29, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

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

OKYO Pharma
info@okyopharma.com
OKYO Pharma Floor 4, 14/15 Conduit St London W1S 2XJ

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria

Approval based on phase 3 studies demonstrating Dupixent significantly reduced itch and hives compared to placebo In the US, there are more than 300,000 adults and adolescents aged 12 years...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 18, 2025

Regeneron
ukinfo@regeneron.com
The Charter Building, Vine Street, Uxbridge, Middlesex, United Kingdom, UB8 1JG

Sanofi’s respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD

New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma Lunsekimig now targeting chronic rhinosinusitis and COPD in addition to asthma Itepekimab expanding into chronic rhinosinusitis along with...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Eleva Publishes Evidence of Immunomodulation and Neuroprotection Using its Factor H Biological Therapy in Preclinical Dry AMD Study

Eleva confirms dry AMD as second indication for proprietary Factor H (CPV-104) program 15 April 2025 -- Freiburg im Breisgau, Germany -- Eleva, a pioneer in discovering and developing previously...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 15, 2025

Eleva Biologics
hello@elevabiologics.com
Hans-Bunte-Str. 19 79108 Freiburg Germany

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

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD

Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in adults with elevated eosinophils Approval marks the first new treatment...

Category: Biotechnology, Clinical Trials, Drug Discovery, Pharmaceutical
Posted: March 28, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK

Tolebrutinib regulatory submission accepted for priority review in the US for patients with multiple sclerosis

If approved, tolebrutinib would be the first and only brain-penetrant BTK inhibitor to both treat non-relapsing secondary progressive multiple sclerosis (MS) and slow disability accumulation independent of relapse activity Tolebrutinib...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 25, 2025

Sanofi
One Onslow Street, Guildford, Surrey, GU1 4YS, UK