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INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray drugs
May 31, 2018
INSYS Therapeutics, Inc. (NASDAQ:INSY), a leader in the development, manufacture and commercialization of pharmaceutical cannabinoids and spray technology, confirmed today that an expert panel convened by the U.S. Food and Drug Administration
FDA Approves Yonsa drugs
May 31, 2018
Sun Pharmaceutical Industries Ltd. and includes its subsidiaries and/or associate companies) and Churchill Pharmaceuticals, LLC.
AcelRx Announces FDA Acceptance of NDA for DSUVIA drugs
May 31, 2018
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the Company), a specialty pharmaceutical company focused on innovative therapies for use in medically supervised settings
GSK Receives FDA Approval of Arnuity Ellipta for Asthma in Children From 5 Years of Age drugs
May 31, 2018
GSK today announced it has received approval from the US Food and Drug Administration (FDA) for the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid (ICS) medicine for the maintenance treatment of asthma in children from as
FDA Approves Palynziq drugs
May 31, 2018
The U.S. Food and Drug Administration today approved Palynziq (pegvaliase-pqpz) for adults with a rare and serious genetic disease known as phenylketonuria (PKU).
FDA Approves 1st Artificial Iris drugs
May 31, 2018
The U.S. Food and Drug Administration on Wednesday gave its OK to the first artificial iris -- the colored part of the eye that surrounds the pupil.
FDA Approves New Treatment for Ulcerative Colitis drugs
May 31, 2018
U.S. Food and Drug Administration approval of Xeljanz (tofacitinib) has been expanded to include adults with active moderate-to-severe ulcerative colitis, the agency said Wednesday.
FDA Approves Imvexxy drugs
May 31, 2018
TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women's healthcare company, today announced that the United States Food and Drug Administration (FDA) has approved Imvexxy (estradiol vaginal inserts) for the treatment of moderate-to-severe dyspareunia (
FDA demonizes pharma over generics, but most company reputations can take the blow May 30, 2018
The FDA is taking pharma to the woodshed again, this time over generic drug stalling tactics.
U.S. FDA Grants Priority Review to Astellas’ New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) firstwordpharma
May 30, 2018
The NDA is based on the ongoing Phase 3 ADMIRAL trial investigating gilteritinib for the treatment of adult patients with FLT3mut+ relapsed or refractory AML. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is November 29, 2

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