Food and Drug Administration (FDA). The drug company is testing an anti-pain drug in the form of extended-release capsules containing only hydrocodone. Groups that ensure that the drug will not result to addiction issues ...
The FDA approved Erivedge in 2012 under the priority review program that provides for an expedited six-month review of drugs that offer major advances in treatment, making it the first licensed medicine for patients with advanced basal cell carcinoma. FDA Approval for Topicort Taro Pharmaceutical In...
Pipeline Previews KYTHERA Biopharmaceuticals Announces FDA Approval of KYBELLA™ KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) announced today that the U.S. Food and Drug Administration (FDA) has approved KYBELLA™, also known as ATX-101, “for improvement in the appearance of moder...
FDA approval of a new drug can send a stock soaring, and these companies have high growth potential.
In 2015, the FDA approved Darzalex for the treatment of multiple myeloma (MM), making it the first CD38 antibody approved globally for MM treatment. Since then, Darzalex has received multiple FDA approvals to expand its scope of treatment for MM patients. Sales have also steadily increased, re...
However, in December 2021, Eohilia received a complete response letter (CRL) indicating that the drug could not be approved in its present form and the FDA recommended an additional clinical study for further consideration. As a result, GlobalData assumed that Takeda would ha...
Peripheral Neuropathy Drug Pipeline Even though the active ingredient in our drug has been used in Asia and Europe, it was never approved in the US in any format, making the drug a new chemical entity (NCE) in the United States. WST-057 has been in development for over ten years. ...
Pipeline innovation in obesity and oncology drugs offsets revenue declines, with 55 novel approvals in 2023[4][8]. Are biosimilars as effective as branded biologics? Yes; FDA requires biosimilars to match efficacy/safety profiles, though clinician adoption remains slow[17]. How does the Inflat...
FDA’s Competitive Generic Therapy (CGT) program accelerates approvals for drugs with <3 competitors[11]. Sterile injectable shortages: Companies like Mark Cuban Cost Plus Drug Company invest in domestic manufacturing ($11M Dallas facility)[1]. Biosimilars: Expanding pipeline for autoimmune and on...
Graphical abstract KEY WORDS 1. Introduction 2. Anti-retroviral drugs approved by FDA 3. Classical ARV drugs in phase III clinical trials 4. ARV drugs in the pipeline for the next 10 years Acknowledgments ReferencesShow full outline Cited by (46) Figures (3) Tables (2) Table 1 Table 2Ac...