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Illustration of double helix
Endocrine/metabolic

Innorna’s mRNA therapy granted US orphan drug designation for Wilson disease

April 28, 2025
Innorna Co. Ltd.’s investigational mRNA therapy, IN-013, has been awarded orphan drug and rare pediatric disease designations by the FDA for the treatment of Wilson disease.
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Concept art for adeno-associated viral-based gene therapy.
Neurology/psychiatric

Blackfinbio’s AAV gene therapy gains IND clearance

April 28, 2025
Blackfinbio Ltd. has obtained IND clearance from the FDA for its novel AAV gene therapy, BFB-101, for hereditary spastic paraplegia type 47 (SPG47), which is caused by changes in the AP4B1 gene. A phase I/II trial will be conducted in the U.S. at Boston Children’s Hospital.
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Photomicrograph of liver biopsy in a patient with cirrhosis, showing bridging septal fibrosis and regenerative nodules.

Mursla Evoliver biopsy blood test granted breakthrough designation

April 25, 2025
By Shani Alexander
The U.S. FDA granted breakthrough device designation to Mursla Bio Ltd.'s Evoliver. The biopsy blood test uses extracellular vesicles to survey hepatocellular carcinoma in high-risk cirrhotic patients.
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US flag, gavel, book

DOJ rolls out task force for review of burdensome regulation

April 25, 2025
By Mark McCarty
The U.S. Department of Justice recently announced the formation of a task force that will advocate the roll-back of regulations that affect a wide swath of sectors of the American economy. Health care is one of the areas of interest for the task force, which will examine state as well as federal regulations.
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Cassidy calls on US Congress to fix longstanding 340B flaws

April 25, 2025
By Mari Serebrov
It’s time for the U.S. Congress to finally put some guardrails on the 340B prescription drug discount program it created more than 30 years ago as a way to help fund health care for low-income patients. That’s the overall conclusion of a majority staff report from the Senate Health, Education, Labor and Pensions Committee that follows a years-long investigation into the program.
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Drug vials and syringe

Vaccine Integrity Project launched to tackle ‘unfortunate reality’

April 25, 2025
By Nuala Moran
Nervousness about the Trump administration’s attitude to vaccines has spurred the formation of the Vaccine Integrity Project, which has the aim of safeguarding the use of vaccines and ensuring vaccine policy “remains grounded in the best available science,” and is “free from external influence.”
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Green approved stamp

Akeso hot with FDA cancer win, nods in China, new data

April 25, 2025
By Randy Osborne
The intriguing VEGFxPD-1 bispecific antibody space gained oomph with phase III results disclosed April 23 by Akeso Pharmaceuticals Inc. related to Harmoni-6, testing ivonescimab in combination with platinum-based chemotherapy compared with Tevimbra (tislelizumab, Beigene Ltd.), a PD-1 inhibitor also paired with platinum-based chemo in patients with locally advanced or metastatic squamous non-small-cell lung cancer irrespective of PD-L1 expression. Those data were followed by a green light from the U.S. FDA April 24 for marketing the PD-1 monoclonal antibody penpulimab in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
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Blood pressure monitor
Cardiovascular

Chinese IND clearance for Rona′s AGT-targeting siRNA drug for hypertension

April 25, 2025
Rona Therapeutics Co. Ltd. has obtained IND clearance from China′s National Medical Products Administration (NMPA) for RN-1871, a small interfering RNA (siRNA) drug targeting angiotensinogen (AGT) for hypertension.
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Immuno-oncology

Kelun-Biotech′s ADC SKB-518 cleared to enter clinic in US

April 25, 2025
Sichuan Kelun-Biotech Biopharmaceutical Co. Ltd. has been granted IND clearance by the FDA for its antibody-drug conjugate (ADC) drug SKB-518.
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Human NK cell
Immuno-oncology

EMA grants IMPD approval for Emercell to study allogeneic NK cell therapy for DLBCL

April 25, 2025
Onward Therapeutics SA’s subsidiary Emercell SAS has received investigational medicinal product dossier (IMPD) approval from the EMA to initiate a phase I trial of OT-C001, an allogeneic natural killer (NK) cell therapy, in combination with an anti-CD20 monoclonal antibody, rituximab.
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