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RSS FeedPosted by Michael Wonder on 27 Aug 2019
Congress should be promoting, not discouraging, the development of biosimilars
27 August 2019 - Drug prices continue to dominate the headlines, yet many of the policy ideas being considered in ...
Posted by Michael Wonder on 27 Aug 2019
We need a more rational biosimilars policy
27 August 2019 - Throwing in the towel on a whole new category of medicines, just shy of a decade in, ...
Posted by Michael Wonder on 27 Aug 2019
FDA approves new add-on drug to treat off episodes in adults with Parkinson's disease
27 August 2019 - The U.S. FDA today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients ...
Posted by Michael Wonder on 27 Aug 2019
Delivering promising new medicines without sacrificing safety and efficacy
27 August 2019 - All drugs approved under the agency’s expedited programs are held to the same approval standards as other ...
Posted by Michael Wonder on 27 Aug 2019
Akorn receives FDA approval for azelastine hydrochloride 0.15% nasal spray
26 August 2019 - Akorn today announced that it received a new Abbreviated new drug application approval from the U.S. FDA ...
Posted by Michael Wonder on 27 Aug 2019
Viela Bio announces U.S. FDA accepts for review inebilizumab biologics license application for neuromyelitis optica spectrum disorder
27 August 2019 - U.S. FDA accepts for review Viela Bio's first BLA filing. ...
Posted by Michael Wonder on 27 Aug 2019
An FDA report reveals the agency believed Novartis data problems were resolved months ago
27 August 2019 - Shortly before serious data problems surfaced in mid-March at a troubled Novartis unit, a Food and ...
Posted by Michael Wonder on 27 Aug 2019
FDA grants fast track designation for Farxiga in chronic kidney disease
27 August 2019 - AstraZeneca today announced that the US FDA has granted fast track designation for the development of ...
Posted by Michael Wonder on 26 Aug 2019
FDA approves US WorldMeds' Myobloc (rimabotulinumtoxinB) injection for chronic sialorrhea
26 August 2019 - Myobloc is the only approved botulinum toxin for chronic sialorrhoea that provides significant results in as early ...
Posted by Michael Wonder on 26 Aug 2019
Developing real-world data and evidence to support regulatory decision-making
26 August 2019 - On 3 October, the FDA and the Duke-Margolis Center for Health Policy will hold a conference, ...
Posted by Michael Wonder on 26 Aug 2019
FDA encourages inclusion of male patients in breast cancer clinical trials
26 August 2019 - The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males ...
Posted by Michael Wonder on 26 Aug 2019
Lilly receives U.S. FDA approval for Taltz (ixekizumab) for the treatment of active ankylosing spondylitis (radiographic axial spondyloarthritis)
26 August 2019 - Eli Lilly and Company announced today that the U.S. FDA has approved Taltz (ixekizumab) injection 80 ...
Posted by Michael Wonder on 26 Aug 2019
Don’t give up on biosimilars—Congress can give them a boost
25 August 2019 - Drugs grown in live cells are hard to replicate. But policy changes can help accelerate the process. ...
Posted by Michael Wonder on 25 Aug 2019
Medipost’s Pneumostem gets FDA’s fast-track designation
23 August 2019 - Medipost said that the U.S. FDA has given a fast- track designation for Pneumostem, a bronchopulmonary ...
Posted by Michael Wonder on 25 Aug 2019
Time for FDA to release complete responses letters? Debate reignites.
23 August 2019 - The idea of the US FDA releasing complete response letters resurfaced this week as Sarepta Therapeutics ...