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FDA Approves Kisqali drugs.com
March 14, 2017
The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy...
Sunovion Submits sNDA to FDA for Use of APTIOM® for the Treatment of Partial-Onset Seizures in Child americanpharmaceuticalreview
March 14, 2017
Sunovion Pharmaceuticals has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for its antiepileptic drug (AED) APTIOM® (eslicarbazepine acetate) to include use as monotherapy or a
FDA accepts the biologics license application for Avelumab for the treatment of metastatic urothelia pharmaasia
March 14, 2017
Merck and Pfizer announced that the US Food and Drug Administration has accepted for Priority Review the Biologics License Application for avelumab
Novartis’ Kisqali® Receives FDA Approval as First-Line Treatment for HR+/HER2- Metastatic Breast Can americanpharmaceuticalreview
March 14, 2017
The US Food and Drug Administration (FDA) has approved Kisqali® (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based therapy for treatment of postmenopausal women with hormone receptor positive, huma
FDA grants orphan drug designation to Boehringer Ingelheim’s antibody BI 836858 pharmaceutical-technology
March 14, 2017
The US Food and Drug Administration (FDA) has granted orphan drug designation to Boehringer Ingelheim’s anti-CD33 ...
FDA grants IND clearance for Servier’s UCART19 to treat relapsed / refractory ALL pharmaceutical-technology
March 14, 2017
The US Food and Drug Administration (FDA) has granted an investigational new drug (IND) clearance to Servier to ...
Trump's FDA pick Gottlieb calls vaccine, autism theories 'thoroughly debunked' fiercepharma
March 14, 2017
Those who counted President Donald Trump an ally against vaccines might be disappointed to hear what his pick to head up the FDA has said on the subject.
Former FDA deputy commissioner Scott Gottlieb heads Trump's picks to lead agency: sources firstwordpharma
March 13, 2017
According to people familiar with the matter, former FDA deputy commissioner Scott Gottlieb is the top choice of US President Donald Trump to lead the agency, several news outlets reported Friday.
FDA Grants Orphan Drug Designation to Boehringer Ingelheim's Investigational Anti-CD33 Monoclonal An americanpharmaceuticalreview
March 13, 2017
Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its anti-CD33 monoclonal antibody BI 836858 for the treatment of myelodysplastic syndromes (MDS).
FDA accepts sNDA for Vraylar cphi-online
March 10, 2017
Application seeks to expand Vraylar label to include Phase III clinical data for the maintenance treatment of schizophrenia.

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