Approvals

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).

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.

Takeda receives FDA approval for Vonvendi sBLA

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.

FDA grants breakthrough therapy status to Eli Lilly’s olomorasib

Eli Lilly has received the US Food and Drug Administration (FDA) has granted breakthrough therapy designation to olomorasib, an investigational KRAS G12C inhibitor.

EMA grants orphan designation to Aldeyra’s ADX-2191 for vitreoretinal lymphoma

Aldeyra Therapeutics has secured orphan designation from the European Medicines Agency (EMA) for ADX-2191, an intravitreal injection of methotrexate, intended for primary large B-cell lymphomas in immune-privileged sites, such as primary vitreoretinal lymphoma.