Regulation

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.

Bristol-Myers Squibb gets FDA breakthrough therapy status for Orencia to prevent GvHD

Bristol-Myers Squibb (BMS) has secured breakthrough therapy status from the US Food and Drug Administration (FDA) for its Orencia (abatacept) to prevent moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.

Bristol-Myers Squibb, Acceleron announce FDA advisory committee will review Reblozyl for use in patients with MDS

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.

Roche gets FDA nod for Tecentriq plus chemotherapy to treat metastatic NSCLC

Roche has secured approval from the US Food and Drug Administration (FDA) for its Tecentriq (atezolizumab) plus chemotherapy for the initial treatment of metastatic non-squamous non-small cell lung cancer (NSCLC).

Merck’s Keytruda gets FDA priority review for high-risk NMIBC

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).