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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...

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 ...

Gan & Lee’s new blockbuster GRADUAL-3 Clinical Study to fix weight management
02 December 2025

Gan & Lee’s new blockbuster GRADUAL-3 Clinical Study to fix weight management

Announcement Gan & Lee Pharmaceuticals is now entering its third large-scale phase 3 clinical study, GRADUAL-3, of its glucagon-like peptide-1 receptor agonist (GLP-1 RA) bofanglutide injection in the adult population with overweight or obesity. This study will be covering bofanglutide injecti...

Hemostemix plans to kickstart its first two Cardiology Practices via an acquisition strategy
01 December 2025

Hemostemix plans to kickstart its first two Cardiology Practices via an acquisition strategy

Announcement Hemostemix Inc. is delighted to read out the bond letter of its plant for beginning with the first two cardiology practices via acquisition strategy, inspired by the Company’s intelligent commercialisation strategy and clinic roll-up. The intense practices of Dr Hector Rosario F...

Otsuka’s confidence in IgAN win as FDA green signalled First Anti-APRIL Antibody
01 December 2025

Otsuka’s confidence in IgAN win as FDA green signalled First Anti-APRIL Antibody

Announcement After the FDA approved Otsuka’s anti-APRIL antibody sibeprenlimab to alleviate the urine protein level in the IgA nephropathy patient group, this approved drug will be commercialised under the brand name ‘Voyxact’. This regulatory relief will make this drug the first...

Phio completed its enrolment to take a step ahead in the INTASYL siRNA study
28 November 2025

Phio completed its enrolment to take a step ahead in the INTASYL siRNA study

Announcement Phio Pharmaceuticals Corp., a clinical-level siRNA biopharmaceutical company establishing a therapeutic game with its exclusive INTASYL® gene silencing technology to treat cancer, has completed its enrolment process in the Phase 1b clinical trial. It’s a clinical trial of IN...

Novartis’ Zolgensma received FDA approval
28 November 2025

Novartis’ Zolgensma received FDA approval

Announcement Novartis’ intrathecal form of spinal muscular atrophy gene therapy, Zolgensma, received FDA approval. With this approval, Novartis will expand access to this therapy, reaching patients aged 2 years and older. Hearing this advantage from this approval, the Stanford Medicine profe...

The FDA granted permission to Bristol Myers Squibb’s Breyanzi
27 November 2025

The FDA granted permission to Bristol Myers Squibb’s Breyanzi

Announcement Bristol Myers Squibb proudly confirmed that they have officially received a European Commission’s approval stamp on Breyanzi® potential, a CD19-directed chimeric antigen receptor (CAR) T cell therapy. This therapy is for the treatment of adult patients group having refractory...

NervGen’s Peptide reserved for the FDA’s regulatory final
27 November 2025

NervGen’s Peptide reserved for the FDA’s regulatory final

Announcement NervGen’s robust investigational peptide therapeutic, NVG-291, has successfully enhanced the quality of life and improved functional performance in a patient group having chronic spinal cord injury. The drug for the same has been scheduled for late-stage development. NervGen con...

AGC Biologics, getting ready to enter the commercial stage, Inherited Retinal Disorders
26 November 2025

AGC Biologics, getting ready to enter the commercial stage, Inherited Retinal Disorders

Announcement After getting near the end of the tunnel with the AAVantgarde closing of the Series B financing round, AGC Biologics is preparing for a new manufacturing agreement with the biotechnology company. This will be a symbol of AGC Biologics’ brand-new advancement in the adeno-based vi...