Approvals

FDA grants fast track status for GC Biopharma and Novel Pharma’s GC1130A

The US Food and Drug Administration (FDA) has granted fast track designation for GC Biopharma and Novel Pharma's GC1130A, a biological drug for the treatment of MPSIIIA (Sanfilippo syndrome Type A).

Repare Therapeutics secures FDA Fast Track designation for ovarian cancer therapy

Repare Therapeutics has received Fast Track designation from the US Food and Drug Administration (FDA) for lunresertib in combination with camonsertib to treat adult patients with CCNE1 amplified, or FBXW7 or PPP2R1A-mutated platinum-resistant ovarian cancer.

Teva and Alvotech launch SIMLANDI in US for arthritis

Teva and Alvotech have announced the US launch of SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to the reference product Humira to treat arthritis.

Genmab and Pfizer’s TIVDAK sBLA secures full FDA approval

Genmab and Pfizer have announced that the US Food and Drug Administration (FDA) granted full approval to TIVDAK’s (tisotumab vedotin-tftv) supplemental Biologics License Application (sBLA) to treat patients with recurrent or metastatic cervical cancer who have experienced disease progression on or after chemotherapy.

FDA approves Ractigen Therapeutics’ RAG-01 IND for bladder cancer

Ractigen Therapeutics has received approval from the US Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for saRNA therapy RAG-01.

Merck’s PREVYMIS gets Health Canada’s approval for CMV disease prevention

Merck, referred as MSD outside the US and Canada, has confirmed that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high risk adult kidney transplant recipients.

Orladeyo gains approval in Brazil for HAE prevention

Brazil's Health Regulatory Agency (ANVISA) has approved Orladeyo (berotralstat) for the prevention of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 and older, offering a new oral treatment for those suffering from this genetic disorder.

Telix Pharmaceuticals secures FDA fast track status for TLX101-CDx

Telix Pharmaceuticals has received fast track designation from the US Food and Drug Administration (FDA) for its investigational glioma imaging product, TLX101-CDx (Pixclara).

NICE recommends Novartis’ CAR-T therapy for leukaemia

The UK National Institute for Health and Care Excellence (NICE) has recommended the routine use of Novartis' tisagenlecleucel (Kymriah), a chimeric antigen receptor T-cell (CAR-T) therapy, for children and young adults aged up to 25 years with B-cell acute lymphoblastic leukaemia (ALL).