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Zydus settles patent case over Aptalis’ drug Canasa expressbpd
August 15, 2017
Canasa is indicated to treat mildly to moderately active ulcerative colitis
Achieve Announces FDA Acceptance of IND Application for Cytisine americanpharmaceuticalreview
August 14, 2017
Achieve Life Sciences announced the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for cytisine, an established smoking cessation treatment that has been approved and marketed in Central and Eastern Eur
FDA Alerts HCPs, Patients Not To Use Sterile Drug Products from Vital Rx, Dba Atlantic Pharmacy, Com americanpharmaceuticalreview
August 14, 2017
During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces
Neuromodulation player NeoSync grabs $13M for depression trial fiercebiotech
August 14, 2017
Designed to treat depression, the NEST device delivers magentic stimulation to the brain 30 minutes a day, five days a week.
FDA updates gastric balloon warning after 5 deaths fiercebiotech
August 14, 2017
The FDA continues to recommend healthcare providers closely monitor patients implanted with Apollo Endosurgery and ReShape Medical's intragastric balloons.
FDA drafts guidance on post-approval manufacturing for biologics europeanpharmaceuticalreview
August 14, 2017
The FDA has released a draft guidance in response to an increase in the number of post-approval manufacturing supplements…
FDA alarms of Possible Contamination in Multiple Brands of Drugs, Dietary Supplements drugs.com
August 14, 2017
FDA is suggesting consumers and health care professionals not to use any liquid drug or dietary supplement products produced by PharmaTech.
Mylan points finger at FDA for failure to win nods on Advair, Copaxone copies fiercepharma
August 10, 2017
Mylan's sales and profits each missed forecasts for Q2
FDA awards orphan status to new brain cancer vaccine pharmafile
August 10, 2017
The FDA has announced that it has awarded orphan drug status to the vaccine SurVaxM for patients with glioblastoma, the most common form of brain cancer and a condition which affects 14,000 new patients in the US every month.
FDA to expand public education campaign to focus on prevention of youth e-cigarette use worldpharmanews
August 10, 2017
he U.S. Food and Drug Administration announced it would pursue a strategic, new public health education campaign aimed at discouraging the use of e-cigarettes and other electronic nicotine delivery systems (ENDS) by kids.

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