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).
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.
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 has secured fast track designation from the US Food and Drug Administration (FDA) for ADCE-D01 to treat soft tissue sarcoma (STS).
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.
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.
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).
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).
The European Commission (EC) has sanctioned the use of Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat tenosynovial giant cell tumour (TGCT) in adults.
Takeda Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for the supplemental Biologics License Application (sBLA) of an expanded indication for Vonvendi, for routine prophylaxis in adults with von Willebrand disease (VWD), including Types 1 and 2.
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