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FDA clears Newron, Zambon, US WorldMeds' Xadago for Parkinson's disease firstwordpharma
March 22, 2017
The FDA approved Newron Pharmaceuticals, Zambon and US WorldMeds' Xadago (safinamide) as an add-on therapy to levodopa/carbidopa for patients with Parkinson's disease, the companies announced Tuesday.
FDA Approves Xadago drugs.com
March 22, 2017
FDA Approves Xadago (safinamide) as an Add-On Treatment for Patients with Parkinson’s Disease
Divis Labs gets US FDA import alert financialexpress
March 22, 2017
The company has announced that it is working with third party consultants to address concerns of USFDA
Bausch + Lomb and Nicox Announce PDUFA Date for Novel Glaucoma Candidate Latanoprostene Bunod americanpharmaceuticalreview
March 22, 2017
Valeant Pharmaceuticals International, Inc.'s wholly owned subsidiary, Bausch + Lomb, and Nicox S.A. announced that the U.S. Food and Drug Administration (FDA) has set a PDUFA date of August 24, 2017...
FDA Approves Juvéderm Vollure XC drugs.com
March 21, 2017
Allergan plc, (NYSE: AGN), a leading global pharmaceutical company announced that the company has received approval from the U.S. Food and Drug Administration (FDA) to market Juvéderm Vollure™ XC.
FDA warns API manufacturer about river water as ingredient pharmafile
March 20, 2017
The FDA has issued Badrivishal Chemicals & Pharmaceuticals a warning letter regarding numerous violations of manufacturing codes.
AstraZeneca Receives Complete Response Letter from FDA for ZS-9 for Hyperkalaemia americanpharmaceuticalreview
March 20, 2017
AstraZeneca announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for ZS-9 (sodium zirconium cyclosilicate).
FDA warns China's Lumis over misbranded APIs pharmafile
March 17, 2017
Chinese firm Lumis Global Pharmaceuticals became the latest to face the FDA’s ire as it was hit by a warning over its active pharmaceutical ingredient (API) facility in Hubei, China.
Proposed US budget for 2018 sees rise in FDA user fees to over $2 billion firstwordpharma
March 17, 2017
Under US President Donald Trump's proposed budget for 2018 released Thursday, the FDA would collect more than $2 billion in fees from industries that use its services...
Endo Releases Statement on FDA Advisory Committees' Vote Related to OPANA® ER americanpharmaceuticalreview
March 17, 2017
Endo International announced that the U.S. Food and Drug Administration's (FDA) Drug Safety Risk Management and Anesthetic and Analgesic Drug Products Advisory Committees voted 18 to eight...

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