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Novo petitions FDA to require Victoza copies to go through clinical trials, pointing to complex manu fiercepharma
October 10, 2017
With one drugmaker already trying to pry patent protection off of Novo Nordisk’s blockbuster Victoza before its 2022 expiration, the insulin specialist has taken new steps to deter copies.
FDA approves LivaNova’s device combo to treat drug-resistant epilepsy fiercebiotech
October 10, 2017
LivaNova snagged twin FDA approvals for an implantable generator and a programming system, which make up its Vagus Nerve Stimulation Therapy System for the treatment of drug-resistant epilepsy.
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).

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