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FDA Expands Approval of Sprycel americanpharmaceuticacreview
November 13, 2017
As part of its commitment to children and adolescents with cancer, Bristol-Myers Squibb continues to explore pediatric applications for investigational oncology agents within its broad development program.
Hep-B vaccine four-year battle for FDA approval is finally won pharmafile
November 13, 2017
Dynavax had said it was the last throw of the dice for its hepatitis B vaccine, Hepislav-B – the data pointed to it entering the market as best-in-class but it had received one knock-back after another, culminating in a final three month user fee action d
BioPharmX Receives Concurrence from FDA on Phase 3 Acne Study Plans americanpharmaceuticacreview
November 09, 2017
Consistent with oral minocycline products, BPX-01 is intended for the targeted treatment of non-nodular inflammatory acne vulgaris.
Cellectis reopens the off-the-shelf CAR-T treatment pharmafile
November 09, 2017
Shares in the company spiked initially on the release of the news, before settling at 30 cents higher than before the announcement.
FDA lifts hold on Cellectis’ CAR-T trial, adds go-slow caveat fiercebiotech
November 08, 2017
The FDA has lifted the clinical hold it placed on Cellectis’ CAR-T trials in September following the death of a patient.
FDA Approves First Treatment for Erdheim-Chester Disease americanpharmaceuticacreview
November 08, 2017
The U.S. Food and Drug Administration (FDA) expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood.
FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer worldpharmanews
November 08, 2017
The U.S. Food and Drug Administration has expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood
VIMPAT Approved by FDA to Treat Partial-Onset Seizures in Pediatric Epilepsy Patients americanpharmaceuticacreview
November 07, 2017
This new approval provides clinicians with the option to prescribe VIMPAT to their pediatric patients either as an oral solution or a convenient tablet.
Artemis Therapeutics Receives Orphan Drug Designation from FDA for Artemisone americanpharmaceuticacreview
November 07, 2017
Artemis Therapeutics announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation for Artemisone, the company's lead product candidate, for the treatment ofmalaria.
GSK's experimental multiple myeloma scores Breakthrough designation with FDA pharmafile
November 06, 2017
GlaxoSmithKline is celebrating the FDA's decision to grant its experimental therapy GSK2857916 a breakthrough therapy designated as monotherapy in patients with multiple myeloma

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