Regulation

Portal Therapeutics receives FDA orphan, fast track designations for PORT-77

GondolaBio’s affiliate Portal Therapeutics has received orphan drug and fast track designations from the US Food and Drug Administration (FDA) for PORT-77, an investigational oral ABCG2 inhibitor, aimed at treating X-linked protoporphyria (XLP) and erythropoietic protoporphyria (EPP).

FDA accepts Chiesi triple combination inhaler application for asthma

Chiesi USA has announced the US Food and Drug Administration (FDA) acceptance for its New Drug Application (NDA) for triple combination inhaler for the maintenance treatment of asthma in adults.

US FDA grants BeOne’s sonrotoclax breakthrough designation for MCL

BeOne Medicines has received breakthrough therapy designation (BTD) from the US Food and Drug Administration (FDA) for sonrotoclax, an investigational, next-generation BCL2 inhibitor intended for adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Adcendo receives FDA fast track status for ADCE-D01 to treat STS

Adcendo has secured fast track designation from the US Food and Drug Administration (FDA) for ADCE-D01 to treat soft tissue sarcoma (STS).

Bio-Thera, Intas extend partnership for golimumab biosimilar

Bio-Thera Solutions has expanded its partnership with Intas Pharmaceuticals through a licence agreement and exclusive commercialisation for BAT2506, a proposed golimumab biosimilar, in Canada.

FDA accepts priority review for Orca Bio’s hematological malignancy therapy

The US Food and Drug Administration (FDA) has accepted priority review of Biologics Licence Application (BLA) for Orca Bio’s lead investigational allogeneic T-cell immunotherapy Orca-T.

FDA fast-tracks Alto Neuroscience’s ALTO-101 for CIAS treatment

The US Food and Drug Administration (FDA) has awarded Fast Track designation to Alto Neuroscience’s ALTO-101, a novel small molecule phosphodiesterase-4 (PDE4) inhibitor for the treatment of cognitive impairment linked to schizophrenia (CIAS).

J&J’s Tremfya gets FDA approval for SC induction in active UC

Johnson & Johnson (J&J) has secured approval from the US Food and Drug Administration (FDA) for a subcutaneous (SC) induction regimen of Tremfya (guselkumab) in adults with moderately to severely active ulcerative colitis (UC).

Deciphera’s Romvimza secures EC nod for TGCT treatment

The European Commission (EC) has sanctioned the use of Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat tenosynovial giant cell tumour (TGCT) in adults.