Alnylam Pharmaceuticals has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1 (PH1).
Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).
Incyte announced the validation of the Company’s Marketing Authorization Application (MAA) for pemigatinib for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.
AstraZeneca’s Farxiga (dapagliflozin) has been granted priority review from the US Food and Drug Administration (FDA) for a certain population of patients with heart failure.
Biopharmaceutical company Ipsen has secured approval from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its Dysport as a symptomatic treatment for upper limb spasticity in children with cerebral palsy.
AstraZeneca and Merck have secured approval from the US Food and Drug Administration (FDA) for Lynparza (olaparib) as a first-line maintenance treatment for germline BRCA-mutated metastatic pancreatic cancer.
Roche has secured approval from the European Commission (EC) for its Kadcyla (trastuzumab emtansine) as an adjuvant (after surgery) treatment for people with HER2-positive early breast cancer (eBC).
Astellas Pharma and Seattle Genetics have secured accelerated approval from the US Food and Drug Administration (FDA) for Padcev (enfortumab vedotin-ejfv) to treat people with locally advanced or metastatic urothelial cancer.
Pfizer announced that the US Food and Drug Administration (FDA) has accepted and granted priority review to the company’s supplemental New Drug Application (sNDA) for BRAFTOVI (encorafenib) in combination with ERBITUX (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the efficacy and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy.
Merck said that a committee of the US Food and Drug Administration (FDA) has recommended approval of Keytruda for the treatment of certain patients who are highly prone to non-muscle invasive bladder cancer (NMIBC).
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