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BioWorld - Monday, December 22, 2025
Home » Topics » Regulatory, BioWorld Science

Regulatory, BioWorld Science
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3D illustration of cancer in crosshairs
Cancer

Pasithea Therapeutics eyes IND filing for MEK1/2 inhibitor PAS-004 following FDA guidance

Nov. 30, 2023
Pasithea Therapeutics Corp. has received written responses from the FDA to questions submitted for a type 2 pre-IND meeting regarding the clinical development plan for PAS-004 (CIP-137401).
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Microenvironment of a HER2-expressing breast tumor
Immuno-oncology

Carisma's HER2-targeting CT-0525 cleared to enter clinic

Nov. 29, 2023
Carisma Therapeutics Inc. has received FDA clearance of its IND application for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor (CAR)-monocyte cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
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Bloodstream with red and white blood cells and platelets
Hematologic

Sernova’s hemophilia cell therapy program awarded US orphan drug designation

Nov. 28, 2023
Sernova Corp. has announced that its hemophilia A program, combining the Sernova Cell Pouch with a patient’s own cells corrected for the production of factor VIII (FVIII), has been awarded U.S. orphan drug and rare pediatric disease designations.
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Infection

Ethris gains clearance for phase I study of ETH-47 for respiratory viral infections

Nov. 28, 2023
Ethris GmbH has received approval from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with a first-in-human trial of its inhaled mRNA program, ETH-47, in healthy participants for the treatment and prophylaxis of respiratory viral infections.
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Cancer

CSPC Pharmaceutical’s SOS-1 inhibitor cleared to enter clinic in China for solid tumors

Nov. 28, 2023
CSPC Pharmaceutical Group Ltd.’s selective son of sevenless homolog 1 (SOS-1) inhibitor SYH-2038 has received clearance by China’s National Medical Products Administration (NMPA) to enter clinical trials in China.
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Silhouettes
Neurology/Psychiatric

Neumora’s M4 receptor positive allosteric modulator enters clinic for schizophrenia

Nov. 27, 2023
Neumora Therapeutics Inc. has announced IND clearance and initiation of a phase I study of NMRA-266 in healthy adults.
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Antibody-drug conjugate
Immuno-oncology

Henlius’ EGFR-targeting ADC receives FDA clearance to enter clinic for solid tumors

Nov. 24, 2023
Shanghai Henlius Biotech Inc. has announced IND approval by the FDA for HLX-42 for injection, an antibody-drug conjugate (ADC) developed under a collaboration between Henlius and Medilink Therapeutics.
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Cross section illustration of HIV virus parts
HIV/AIDS

Arenaviral therapeutic vaccine HB-500 gets IND clearance for HIV

Nov. 21, 2023
Hookipa Pharma Inc. has received clearance from the FDA for its IND application for HB-500, a novel arenaviral therapeutic vaccine for the treatment of HIV.
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Substance Use & Poisoning

NT-I7 awarded US orphan drug designation for radiation poisoning

Nov. 21, 2023
The FDA has awarded orphan drug designation to Neoimmunetech Inc.'s NT-I7 (efineptakin alfa, rhIL-7-hyFc) for the treatment of acute radiation syndrome (ARS). NT-I7, a novel long-acting recombinant human IL-7, has the potential to rapidly recover and improve the immune response following a high dose of radiation exposure.
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Genitourinary/Sexual Function

Kanna Health’s KH-001 for premature ejaculation cleared to enter clinic

Nov. 17, 2023
Kanna Health Ltd. has received clearances by the FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its IND application and clinical trial application (CTA), respectively, to initiate a first-in-human phase I trial of KH-001 besylate (KH-001) for premature ejaculation.
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