Genentech, a subsidiary of the Roche Group, has received the US Food and Drug Administration’s (FDA) accelerated approval for Lunsumio VELO subcutaneous (SC) formulation to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy.
Cytokinetics has announced that the US Food and Drug Administration (FDA) has approved MYQORZO (aficamten) tablets in 5mg, 10mg, 15mg, and 20mg doses for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to enhance functional capacity and symptoms.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a call for evidence seeking input from the healthcare providers, industry, public, and clinicians on AI regulation in national healthcare.
China’s National Medical Products Administration (NMPA) has granted approval for Boehringer Ingelheim’s Jascayd (nerandomilast) to treat progressive pulmonary fibrosis (PPF).
Biogen has received a notice of compliance (NOC) from Health Canada for Zurzuvae (zuranolone), a neuroactive steroid (NAS), as a treatment for moderate or severe postpartum depression (PPD) in women.
Roche has received approval from the European Commission (EC) for its humanised monoclonal antibody Gazyva/Gazyvaro (obinutuzumab) along with mycophenolate mofetil (MMF), for adults with active Class III or IV lupus nephritis, with or without concomitant Class V.
Eli Lilly and Company has received approval from the US Food and Drug Administration (FDA) for the expanded use of Jaypirca (pirtobrutinib) tablets, in 100mg and 50mg doses, to treat adults with relapsed or refractory chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
Lotus Pharmaceutical has submitted a new drug application (NDA) to the Ministry of Food and Drug Safety (MFDS) for VIZZ (aceclidine ophthalmic solution) 1.44%, seeking approval in South Korea for presbyopia treatment in adults.
Eisai has submitted a new drug application seeking approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for Leqembi’s (lecanemab) subcutaneous (SC) formulation (SC-AI) for early Alzheimer’s disease.
Lupin has received US Food and Drug Administration (FDA) approval for Armlupeg (pegfilgrastim-unne) 6mg/0.6ml injection in a single-dose prefilled syringe for subcutaneous use as a biosimilar to Neulasta (pegfilgrastim).
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