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STA Pharmaceutical’s Changzhou facility passes first FDA inspection

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STA Pharmaceutical (WuXi STA), a subsidiary of WuXi AppTec has announced that its active pharmaceutical ingredient (API) R&D and manufacturing facility in Changzhou, China, has passed its first inspection by the US Food and Drug Administration (FDA).

FDA approves two drugs for treatment of BRAF-positive anaplastic thyroid cancer

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Two drugs, to be administered together for the treatment of ATC that cannot be surgically removed or has spread and has a type of abnormal gene, BRAF V600E, Tafinlar (dabrafenib) and Mekinist (trametinib), have been approved by the FDA

Genmab receives approval for its treatment for newly diagnosed multiple myeloma

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Biotechnology company, Genmab, has announced that the FDA has approved the use of DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnos

FDA files for permanent injunctions against two stem cell clinics

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The FDA has filed two complaints in federal in court, in which it is seeking permanent injunctions against two stem cell clinics to prevent them from marketing stem cell products without FDA approval and for cGMP deviations

Biosimilar entry onto US market slow despite action by FDA, says GlobalData

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Biosimilar entry onto US market is slow despite implementation of the Biologics Price Competition and Innovation Act (BPCIA) by the Food and Drug Administration (FDA), according to data and analytics company, GlobalData.

FDA approves treatment for MS in paediatric population

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A treatment for relapsing multiple sclerosis (Gilenya — fingolimod) has been approved for use in children and adolescents aged 10 years and older by the US Food and Drug Administration (FDA).

Orchard Therapeutics receives Rare Pediatric Disease Designation from FDA

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Orchard Therapeutics, a commercial stage company, has been granted a Rare Pediatric Disease Designation from the US Food and Drug Administration (FDA) for its gene therapy candidate, OTL-200, for the treatment of patients with MLD

Big data analysis reveals ability of animal studies to predict human safety

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The ability of animal studies to predict human safety has been evaluated by global information analytics business, Elsevier, through big data analysis of adverse events reported to the US FDA and EMA

ISCT announces support of FDA’s action against two stem cell clinics

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The ISCT International Society Cell and Gene Therapy has announced its support of the US Food and Drug Administration’s request for injunctions against two US stem cell clinics that have administered unproven cellular therapy treatments to patients.

New preventative migraine treatment from Amgen receives FDA approval

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A novel treatment for the prevention of migraines, Aimovig (erenumab-aooe), has received approval from the US Food and Drug Administration (FDA).

FDA publishes list of companies that have potentially used ‘gaming’ tactics to delay generics

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Commissioner of the US Food and Drug Administration (FDA), Dr Scott Gottlieb, has released a statement highlighting new efforts to raise awareness of situations where drug makers may be ‘pursuing gaming tactics to delay generic competition’

FDA approves drug to treat low platelet count in patients with chronic liver disease

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The US Food and Drug Administration (FDA) has approved Doptelet (avatrombopag) tablets — a new drug for the treatment of patients with chronic liver disease who have low blood platelets and are undergoing a medical or dental procedure.

Diagnostic tech to play an important role in improving flu tests

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New diagnostic technology set to play an important part in improving the quality of testing for influenza in order to meet new US Food and Drug Administration (FDA) criteria.

The top five tweets: From migraines to webinars — what have EPM readers clicked on this week?

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Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics.

FDA accepts supplemental new drug application for Promacta and grants it priority review

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The US FDA has accepted Novartis’ supplemental new drug application (sNDA) and granted priority review designation to Promacta (eltrombopag) in combination with standard immunosuppressive therapy (IST) for first-line treatment of SAA

The top five tweets: From financing to big data — what did EPM readers enjoy reading this week?

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Here we count down the top five tweets from @EPM_magazine that have gained the most impressions this week, taken from Twitter analytics.

A small dose — a capsule view of some key developments in the industry, June 2018

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A brief round-up of some of the developments in the industry including a step in the right direction for oral insulin and an overview of Alantra Pharma’s Fast 50 index…

Senator Schumer urges FDA to pull ‘sunscreen pills’ from market completely

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US senator, Charles Schumer, has urged the Food and Drug Administration (FDA) to remove ‘sunscreen pills’ — which promise SPF-like protection — from the market before the summer season starts.

Certara to be part of the team to gain FDA approval for moxidectin

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Certara, decision support technology and consulting organisation, has celebrated an important milestone for its public health drug development and treatment consulting portfolio as it is engaged as part of the team to gain FDA approval of moxidectin

FDA approves Shire’s new plasma manufacturing facility

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Global biotechnology company, Shire, has received approval from the US Food and Drug Administration (FDA) for its first submission of its new plasma manufacturing facility near Covington, Georgia, where Gammagard Liquid will be produced.
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