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INSYS Therapeutics Confirms Outcome of FDA Advisory Committee Meeting on Buprenorphine Sublingual Spray
drugs
June 12, 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) voted
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FDA to Review Zynquista (sotagliflozin) as Potential Treatment for Type 1 Diabetes
drugs
June 12, 2018
The U.S. Food and Drug Administration (FDA) has accepted Sanofi's regulatory filing for Zynquista (sotagliflozin). The investigational oral treatment would be used in addition to insulin therapy to improve blood sugar control in adults with type 1 diabete
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FDA Approves Consensi
drugs
June 12, 2018
Kitov Pharma Ltd. (NASDAQ: KTOV; TASE: KTOV), an innovative biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine and celecoxib) oral tablets for marketing.
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FDA Approves Olumiant
drugs
June 12, 2018
Eli Lilly and Company (NYSE: LLY) and Incyte Corporation (NASDAQ: INCY) announced today that the U.S. Food and Drug Administration (FDA) has approved the 2-mg dose of Olumiant (baricitinib),
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FDA Approves Fulphila
drugs
June 12, 2018
HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Fulphil
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FDA Approves Mircera for Anemia Associated with Chronic Kidney Disease in Pediatric Patients on Dialysis
drugs
June 12, 2018
On June 7, 2018, the Food and Drug Administration approved methoxy polyethylene glycol-epoetin beta (Mircera, Vifor Pharma Inc.) for the treatment of pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their h
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FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris
drugs
June 12, 2018
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Rituxan (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV),
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FDA wants social media giants to help crack down on illegal opioid marketers
biospectrumasia
June 08, 2018
The FDA’s latest crackdown targets pharmacies hawking illegal opioids online. The agency issued warning letters this week to nine online pharmacies that run 53 websites selling drugs with suspect monikers like “Roxycodone” and “Tramadol Generic.”
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Kitov's combo gets FDA approval in osteoarthritis and hypertension
pharmafile
June 07, 2018
Israeli biopharmaceutical firm is celebrating the approval in the US of Consensi, a combo of the calcium channel blocker amlodipine and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, after the FDA authorised the drug for the treatment of osteo
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FDA greenlights Lilly's Olumiant in rheumatoid arthritis, with major caveats
pharmafile
June 07, 2018
Eli Lilly has announced that its oral JAK inhibitor Olumiant (baricitinib) has received FDA approval for the treatment of moderately-to-severely active rheumatoid arthritis (RA) in adult patients who have had an inadequate response to one or more tumour n