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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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Immuno-oncology

Tagworks advances TGW-101 into phase I following IND clearance

April 25, 2025
Tagworks Pharmaceuticals BV has received IND clearance from the FDA for a phase I trial evaluating its antibody-drug conjugate (ADC) TGW-101 in patients with advanced solid tumors. The company has initiated the first-in-human trial.
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World with digital overlay
MedCon 2025

Differences in risk classification schema not necessarily a bar on reliance

April 24, 2025
By Mark McCarty
Regulatory reliance is all the rage of late, but some nations employ a four-tier risk classification scheme while others use a three-tier scheme.
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Mark Cook with Minder implant

Epiminder wins de novo clearance for epilepsy EEG monitor

April 24, 2025
By Tamra Sami
The U.S. FDA has granted de novo clearance for Epiminder Pty. Ltd.’s Minder implantable device for continuously monitoring brain activity in patients with epilepsy.
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Cyber security padlock
MedCon 2025

Documentation a common tripwire for FDA cybersecurity submissions

April 24, 2025
By Mark McCarty
The U.S. FDA’s authority to require cybersecurity measures in premarket submissions is a radical change for industry, but firms must document that they have erected solid cybersecurity measures.
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Meeting illustration

Clarification: Nonvoting industry adcom members still possible

April 24, 2025
By Mari Serebrov
In all practicality, U.S. FDA Commissioner Marty Makary’s recently announced policy directive removing industry representatives from the agency’s advisory committees may have little effect on the makeup of the drugs and devices committees, which typically include them as nonvoting members.
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Illustration of diseased kidney

Kidneyintelx test leads to increased use of SGLT2 inhibitors

April 23, 2025
By Shani Alexander
The use of Renalytix plc’s Kidneyintelx biomarker-based prognostic test led to increased and targeted use of sodium-glucose cotransporter 2 (SGLT2) inhibitors in patients at risk of diabetic kidney disease, compared to untested patients, according to data from a study.
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Laptop displaying FDA logo

MDMA’s Leahey skeptical of reports of the demise of user fees

April 23, 2025
By Mark McCarty
Staffing cuts at the FDA’s device center led to speculation that the current user fee program may be fatally damaged, but Mark Leahey, president and CEO of the Medical Device Manufacturers Association, said in a meeting in Columbus, Ohio that there are too many resources for FDA at stake for the user fee program to be ended.
Read More
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