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FDA Awards 15 Grants for Clinical Trials to Stimulate Product Development for Rare Diseases pharmaceufical-technology
October 10, 2017
A total of 76 grant applications were received for this fiscal year, with a funding rate of 20 percent. The grant recipients for fiscal year 2017 are the following:
FDA panel pans PTC’s post hoc pitch, shredding DMD dream fiercebiotech
September 30, 2017
A panel of experts convened by the FDA has overwhelmingly knocked back PTC Therapeutics’ filing for approval of ataluren.
FDA Improves Access to Reports of Adverse Drug Reactions americanpharmaceuticacreview
September 30, 2017
The FDA has launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS).
FDA Approves New Treatment for Certain Advanced or Metastatic Breast Cancers americanpharmaceuticacreview
September 30, 2017
It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread (metastasized).
Lupin receives FDA approval for generic Acticlate tablets expressbpd
September 30, 2017
They are indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne
Makers of immediate-release opioids must fund training on their use, FDA says pharmafile
September 30, 2017
As part of its ongoing response to the opioid crisis in the US which is claiming the lives of over 100 citizens a day
FDA approves Verzenio for metastatic breast cancer europeanpharmaceuticalreview
September 30, 2017
The FDA has approved Verzenio to treat advanced or metastatic breast cancer that has progressed after taking therapy…
FDA improves access to reports of adverse drug reactions worldpharmanews
September 29, 2017
The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS).
FDA Accepts Supplemental NDA for Lenvatinib as Liver Cancer Treatment americanpharmaceuticacreview
September 28, 2017
There is no guarantee that any investigational uses of such FDA-approved product will gain FDA approval.
FDA Announces Support Plans for Puerto Rico americanpharmaceuticacreview
September 28, 2017
First and foremost, these efforts are focused around our mission driven responsibilities to ensure the safety of the medical products, blood and the food supply needed by residents of the island.

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