Business Wire1d
Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
JD Supra1d
FDA Issues ACNU Final Rule Establishing New Requirements for Nonprescription Drugs with an Additional Condition for Nonprescription Use
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
News Medical1d
Researchers launch startup to revolutionize targeted drug delivery using milk exosomes
Two Nebraska researchers have launched a startup company aimed at bringing to market an innovative method for delivering therapeutics, gene editing tools, plasmids and more to targeted locations in ...
Science Daily2d
Scientists develop 'Malteser-like' molecules with potential applications in targeted drug delivery
Scientists have taken a major step forwards in tackling one of the greatest abiding challenges in chemistry, by learning how to program the self-assembly of molecules in such a way that the end result ...
MedPage Today2d
HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals
Of the 24 drugs, three approvals deviated from the others -- aducanumab; the synthetic hormone hydroxyprogesterone caproate ...
Newsom committed California to making its own insulin. It’s at least a year behind his schedule
California is not one of those states. Newsom in October rejected a $35 monthly insulin copay cap. In his veto message, he cited the state’s $100 million investment in insulin production as an example ...
Windtree Strengthens Global Intellectual Property Portfolio with New Japanese Patent For the Company’s Oncology Pipeline
“Issuance of the new patent for our oncology preclinical aPKCi inhibitor pipeline is an important part of our development strategy,” said Jed Latkin, CEO of Windtree Therapeutics. “We will continue ...
J&J Initiates Bid for FDA Approval of TAR-200 in Bladder Cancer
The New Brunswick, N.J., pharmaceutical giant said the FDA accepted the application through its Real-Time Oncology Review program, which allows for an earlier submission of topline efficacy and safety ...
JD Supra5d
The Commercial Potential – and Practical Challenges – of Marketing OTC Drugs With ‘Additional Conditions for Nonprescription Use’
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some ...
Fewer delays, more launches of cancer drugs found in higher income countries
The development of new drugs is critical in treating cancer—if people have access to them. A team co-led by Penn State ...
Billed as nonaddictive, new pain pill could soon win FDA approval
A non-opioid painkiller from Vertex Pharmaceuticals could become a blockbuster, but questions remain on whether it will prove ...