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.
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).
Horizon Therapeutics announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) of the US Food and Drug Administration (FDA) voted unanimously that the potential benefits of teprotumumab, a fully human monoclonal antibody (mAb), outweigh the potential risks for the treatment of Thyroid Eye Disease (TED).
The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping.
Dermira has secured fast track designation from the US Food and Drug Administration (FDA) for lebrikizumab for the treatment of moderate-to-severe atopic dermatitis.
ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection.
Bristol-Myers Squibb and Acceleron Pharma said that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will hold a review of Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for the use of Reblozyl (luspatercept-aamt) in patients with myelodysplastic syndromes (MDS) at its meeting on December 18, 2019.
Merck said that its anti-PD-1 therapy Keytruda has been granted priority review by the US Food and Drug Administration (FDA) in certain patients with high-risk, non-muscle invasive bladder cancer (NMIBC).
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