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FDA Advisory Committee recommends approval of Pfizer's proposed biosimilar to Epogen® / Procrit® acr worldpharmanews
May 27, 2017
Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company's proposed epoetin alfa biosimilar across all indications.
FDA approves first cancer treatment for any solid tumor with a specific biomarker europeanpharmaceuticalreview
May 25, 2017
The US Food and Drug Administration (FDA) granted accelerated approval to a treatment for patients whose cancers have a specific genetic feature (biomarker).
FDA approves Kevzara for the treatment of moderately to severely active RA in adults cphi-online
May 25, 2017
Kevzara is now available to US patients.
FDA Slaps Clinical Hold on Concert Pharma (CNCE)'s Hair Loss Drug BioSpace.com
May 22, 2017
The U.S. Food and Drug Administration (FDA) placed a clinical hold on Concert Pharmaceuticals (CNCE)’ CTP-543 Phase IIa clinical trial for alopecia areata, a common autoimmune skin disease that causes hair loss.
FDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests drugs.com
May 18, 2017
The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States.
FDA Expands Approved Use of Kalydeco to Treat Additional Mutations of Cystic Fibrosis drugs.com
May 18, 2017
The U.S. Food and Drug Administration today expanded the approved use of Kalydeco (ivacaftor) for treating cystic fibrosis.
Abon Received Approval from FDA for Clofarabine Injection americanpharmaceuticalreview
May 18, 2017
Abon Pharmaceuticals announced it has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Clofarabine Injection, 20 mg/20 mL, Single-use Vial.
FDA Grants Bayer Priority Review for Investigational Compound Copanlisib americanpharmaceuticalreview
May 18, 2017
Bayer announced the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for the New Drug Application (NDA) for copanlisib for the treatment of relapsed or refractory follicular lymphoma (FL) patients who have received at least
Cytokinetics receives FDA orphan drug status for Ck-2127107 to treat SMA pharmaceutical-technology
May 18, 2017
Biopharmaceutical company Cytokinetics’ CK-2127107has received orphan drug designation from the Office of Orphan Products Development of the US Food and Drug Administration (FDA) for the potential treatment of spinal muscular atrophy (SMA).
Vifor Pharma and Akebia to sell Vadadustat to Fresenius Medical Care pharmaceutical-technology
May 18, 2017
Vifor Pharma Group and Akebia Therapeutics have entered an exclusive license agreement to sell Vadadustat to Fresenius Medical Care dialysis clinics located in the US after securing approval from the US Food and Drug Administration (FDA).

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