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New UK/EU Rules and technologies lined up for next year
08 December 2025

New UK/EU Rules and technologies lined up for next year

Announcement With the year ending, the UK/EU healthcare regulatory body bundled up new rules and specified the new technologies (AI/ML) adoption to achieve a successful start. The new UK clinical trial rules will be officially unveiled in 2026. Alongside, the EU Biotech Act has exponentially reach...

FDA approved enGene’s solution to participate in the CMC and CDRP program
05 December 2025

FDA approved enGene’s solution to participate in the CMC and CDRP program

Announcement enGene Holdings Inc., a known clinical level non-viral genetic medicines company, proudly declared its detalimogene voraplasmid selection by the FDA for its Pilot program to contribute to the manufacturing readiness. The detalimogene voraplasmid is also known as detalimogene and was pr...

PharmaTher concludes sale of Ketamine ANDA to bring the focus back to long-standing injectable ketamine franchise authorisation
05 December 2025

PharmaTher concludes sale of Ketamine ANDA to bring the focus back to long-standing injectable ketamine franchise authorisation

Announcement PharmaTher Holdings Ltd., a known speciality life sciences company dedicated to unveiling the therapeutic capabilities of ketamine for neuropsychiatric disorders, has confirmed its closing of the existing declared sale of its Abbreviated New Drug Application (ANDA#217858) for Ketamine...

tiakis Biotech finalised its data package to invest in the clinical trial for PAH
05 December 2025

tiakis Biotech finalised its data package to invest in the clinical trial for PAH

Announcement tiakis Biotech AG, a leading clinical-level biopharmaceutical company conquering novel therapeutics for cardiovascular and life-threatening pulmonary disease, confirmed the completion of its robust data package to upgrade Tiprelestat into a Phase 2 clinical trial in Pulmonary Arterial...

TempraMed inked an Exclusive Commercial Distribution deal with Dolfin
05 December 2025

TempraMed inked an Exclusive Commercial Distribution deal with Dolfin

Announcement TempraMed Technologies Ltd., a leading innovator of advanced temperature-controlled medical devices, is honoured to announce its definitive exclusive distribution partnership with Dolfin Sağlık Ürünleri. The intention of TempraMed to join hands with this Turkish company is ...

Cleveland’s IsoPSA® IVD kit received FDA approval
04 December 2025

Cleveland’s IsoPSA® IVD kit received FDA approval

Announcement Cleveland Diagnostics, Inc., an advanced commercial-level precision oncology company, proudly shared its FDA approval news for its IsoPSA® in vitro diagnostic (IVD) kit via the Premarket Approval (PMA) process. The IsoPSA is a blood-related test referred to as an aid in the decisio...

Biolexis’ clinical efforts received a call from the 2nd Innovation in Obesity Therapeutics Summit
04 December 2025

Biolexis’ clinical efforts received a call from the 2nd Innovation in Obesity Therapeutics Summit

Announcement Biolexis Therapeutics, an evolving champion in presenting best-in-class inflammation-targeted and next-generation metabolic therapies, proudly announced its selection for the two presentations at the 2nd Innovation in Obesity Therapeutics Summit. To present the company’s clinica...

Cardiol showcased impressive data from its ARCHER study
04 December 2025

Cardiol showcased impressive data from its ARCHER study

Announcement Cardiol Therapeutics Inc., a clinical-level life sciences company known for modernising the anti-fibrotic and anti-inflammatory therapies for heart conditions, has released its strong and impressive data from its ARCHER study. The ARCHER study is a placebo-balanced, randomised, double ...

Lilly’s readiness to bring affordability by cutting down Zepbound prices
04 December 2025

Lilly’s readiness to bring affordability by cutting down Zepbound prices

Announcement After Novo Nordisk reduced the price of its renowned GLP-1 medicines, Eli Lilly is set to put a discount tag on its obesity drug (Zepbound), available via LillyDirect. Here, both pharma companies are trying to reach patients with affordable drugs, but they are stuck in negotiations wi...

Healthcare companies holding on tightly to the Cell Therapy
03 December 2025

Healthcare companies holding on tightly to the Cell Therapy

Uncountable clinical and financial efforts Where many of the giant pharma, including Novo Nordisk and Takeda, left the cell therapy ground and small biotechs closed their operations, a few players are giving their endless efforts to stretch the modality as long as they can. In the last few months, ...