Regulation

Takeda’s LIVTENCITY receives approval in Japan for CMV infections

Takeda has received approval from the Japanese Ministry of Health, Labour and Welfare for LIVTENCITY (maribavir) for the treatment of post-transplant cytomegalovirus (CMV) infections that are refractory to existing anti-CMV therapies.

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).

FDA accepts Eisai’s sBLA for intravenous LEQEMBI to treat early Alzheimer’s

The US Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) filed by Eisai for a monthly dose intravenous (IV) maintenance dose of Eisai and Biogen’s lecanemab-irmb (LEQEMBI) to treat early Alzheimer’s disease (AD).

FDA grants orphan drug status to Agomab’s AGMB-447 for IPF treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Agomab Therapeutics’ AGMB-447, an inhaled small molecule ALK5-inhibitor, for treating idiopathic pulmonary fibrosis (IPF).

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.

FDA accepts BLA for BMS’ subcutaneous nivolumab to treat solid tumours

The US Food and Drug Administration (FDA) has accepted Bristol Myers Squibb’s (BMS) biologics license application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) formulated along with Halozyme’s recombinant human hyaluronidase (rHuPH20) [referred as subcutaneous nivolumab] for previously approved solid tumour indications for the drug.

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.