Regulation

US FDA accepts and grants priority review to sNDA for BRAFTOVI in combination with ERBITUX to treat BRAFV600E-mutant metastatic colorectal cancer after prior therapy

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.

FDA committee recommends approval of Keytruda in high-risk NMIBC

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).

EC grants orphan drug status to Dicerna’s DCR-A1AT to treat congenital A1AT deficiency

Dicerna Pharmaceuticals has secured orphan drug designation from the European Commission (EC) for its DCR-A1AT to treat congenital alpha-1 antitrypsin (A1AT) deficiency.

Pfizer, Astellas secure expanded FDA approval for XTANDI

Pfizer and Astellas Pharma have secured approval for a new indication for XTANDI (enzalutamide) from the US Food and Drug Administration (FDA) to include its use in metastatic castration-sensitive prostate cancer (mCSPC).

FDA Advisory Committee votes unanimously to support use of teprotumumab to treat thyroid eye disease

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).

FDA grants accelerated approval to first targeted treatment for rare DMD mutation

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 secures FDA fast track status for lebrikizumab in atopic dermatitis

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.

Meitheal Pharmaceuticals announces FDA approval of Enoxaparin Sodium Injection, USP

Meitheal Pharmaceuticals, a fully integrated generic injectables company today announced that the US Food and Drug Administration (FDA) has approved Enoxaparin Sodium Injection, USP, the generic equivalent of Lovenox.

ViiV Healthcare seeks FDA approval for fostemsavir to treat HIV-1 infection

ViiV Healthcare is seeking approval from the US Food and Drug Administration (FDA) for its fostemsavir to treat HIV-1 infection.