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January 16, 2020
FDA has granted fast track designation for Novavax’s NanoFlu, a recombinant quadrivalent flu vaccine, for use by adults age 65 years and older.
January 07, 2020
The sNDA was accepted after positive results from a Phase III trial were published in September 2019 that concluded the drug reduced the incidence of cardiovascular death or the worsening of heart failure versus placebo.
January 03, 2020
The numbers of new molecular entities approved in 2019 are close to or exceed FDA’s performance in most previous years.
January 02, 2020
Pressures on FDA will affect industry’s success in bringing new therapies to market.
FDA’s approval rate slowed, but the US agency is still ahead of its international counterparts in green-lighting new drugs for market.
In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.
As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.
Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.
December 18, 2019
The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.
December 12, 2019
Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.