The US Food and Drug Administration (FDA) has approved AbbVie's Imbruvica (ibrutinib) for the treatment of patients with relapsed / refractory (R/R) marginal zone lymphoma (MZL). The indication is approved under accelerated approval, which is ... Pharmaceutical Technology, 20 hours ago
Imbruvica gets US nod for marginal zone lymphoma - CPhI.cn, 1 day ago
U.S. Food and Drug Administration Approval: Cabozantinib for the Treatment of Advanced Renal Cell Carcinoma - Clinical Cancer Research, 1 week ago
The U.S. Food and Drug Administration (FDA) has granted priority review designation of Roche's rheumatoid arthritis medication Actemra for giant cell arteritis (GCA), the Swiss drugmaker said on Tuesday. Posted 24 Jan 2017 14:35 The logo of ...Channel NewsAsia, 21 minutes ago FDA Grants Priority Review for Genentech's Actemra® (Tocilizumab) Supplemental Biologics License Application for Giant Cell Arteritis, a Form of Vasculitis Minyanville, 50 minutes ago U.S. extends review of Roche MS drug Ocrevus by three months Reuters, 1 month ago Novartis leukemia drug wins FDA priority review Reuters, 2 months ago
MUMBAI: The US Food and Drug Administration has sent a notice to Hetero Labs, a supplier of active pharmaceutical ingredients, about possible manufacturing deficiencies at its unit located in Telangana. The FDA issued the Hyderabadbased company Form ...Economic Times, 9 hours ago Lupin Gains On U.S. Drug Regulator's Approval For Generic Antidepressant Bloomberg-Quint, 1 day ago FDA gives go-ahead to Synergy's constipation drug BioPharma Dive, 12 hours ago FDA Approves Trulance for Chronic Idiopathic Constipation PharmaceuticalProcessing, 15 hours ago
Allergan has received U.S. Food and Drug Administration (FDA) approval of RHOFADE (oxymetazoline hydrochloride) cream 1% for the topical treatment of persistent facial erythema associated with rosacea in adults. Approval was based on two ...MedEsthetics Magazine, 10 hours ago US FDA approves Allergan's Rhofade cream to treat persistent facial erythema associated with rosacea PharmaBiz, 2 days ago FDA Accepts For Filing Supplemental New Drug Application sNDA For LILETTA levonorgestrel-releasing intrauterine system 52 mg Pharmacy Choice, 3 days ago FDA Allows Use of E.U.-Approved Topical Drug Due to Shortage Monthly Prescribing Reference, 6 days ago
LEHI, Utah , Jan. 23, 2017 /PRNewswire/ -- Owlet Baby Care has submitted a 510(k) to the U.S. Food and Drug Administration (FDA), seeking clearance for a medical version of the Owlet Smart Sock. The application is now pending review. Owlet shared ...PR Newswire, 11 hours ago
Representatives from the United States Food and Drug Administration (FDA) attended a Board of Directors meeting for the International Refrigerated Transportation Association (IRTA), a Core Partner of the Global Cold Chain Alliance (GCCA), on ...National Provisioner Online, 12 hours ago US FDA lays out expectations on biosimilar interchangeability Korea Herald, 4 days ago FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs JD Supra, 4 days ago Celltrion to expand presence in U.S. with FDA's new guidance Yonhap News Agency, 5 days ago
HEMA Biologics, LLC announced the acceptance by U.S. Food and Drug Administration of the submitted Biologic License Application for Coagulation...
HEMA Biologics, LLC announced the acceptance by U.S. Food and Drug Administration of the submitted Biologic License Application for Coagulation Factor VIIa Recombinant, eptacog beta activated By a News Reporter-Staff News Editor at Clinical ...Pharmacy Choice, 17 hours ago Biocon scales record high as USFDA accepts BLA for proposed biosimilar Trastuzumab Business Standard, 1 week ago US nod for Biocon-Mylan biosimilar Business Line, 1 week ago BIOCON : U.S. FDA Accepts Biologics License Application BLA for Mylan and Biocon's Proposed Biosimilar Trastuzumab 4 Traders, 4 days ago
The US Food and Drug Administration's (FDA's) independent evaluation of medical products for safety and effectiveness prior to granting approval for marketing or new labeled indications is fundamental to assuring the public and clinicians that ...Journal of the American Medical Association, 3 days ago Compliance countdown: Getting ready for next year's food safety regulations Good Fruit Grower, 3 days ago What Happens After It Leaves The Farm? Producing And Processing Safe Food Farms.com, 3 days ago US - FDA notice of public hearing on strategic partnerships to enhance the safety of imported foods Aquafeed, 5 days ago
The Gujarat Food and Drug Administration (FDCA) is planning to collaborate with France based bioMérieux to train and equip FDCA officers on rapid microbial testing as a part of their strategic partnership for knowledge sharing discussed at the ...PharmaBiz, 3 days ago
NetworkNewsBreaks Concert Pharmaceuticals (NASDAQ: CNCE) CTP-656 Obtains Orphan Drug Designation from FDA
Concert Pharmaceuticals (NASDAQ: CNCE) this morning reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for CTP-656, a next generation CFTR potentiator for the treatment of cystic fibrosis. The designation ...4 Traders, 3 days ago US FDA grants orphan drug designation to Yisheng Biopharma's PIKA rabies vaccine PharmaAsia, 2 days ago Concert Pharmaceuticals Receives FDA Orphan Drug Designation for CTP-656 for the Treatment of Cystic Fibrosis PharmaVOICE, 14 hours ago Concert Pharmaceuticals, Inc. Release: Biopharma Receives FDA Orphan Drug Designation For CTP-656 For The Treatment Of Cystic Fibrosis BioSpace, 3 days ago
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