FiercePharma8d
In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list
In accepting the FDA’s motion, U.S. District Judge Mark Pittman put on hold a lawsuit filed by the Outsourcing Facilities ...
The American Journal of Managed Care10d
FDA Approves Imuldosa, a Fifth Biosimilar to Stelara
Imuldosa (ustekinumab-srlf) is the fifth ustekinumab biosimilar referencing Stelara to receive regulatory approval in the US.
pharmaphorum8d
Pfizer rounds out haemophilia portfolio with FDA approval
The once-weekly injectable joins one-shot haemophilia B gene therapy Beqvez (fidanacogene elaparvovec) in Pfizer’s portfolio, ...
CBS News19d
FDA now weighing approval of first new sunscreen ingredient in decades
If the FDA agrees with DSM-Firmenich's request, the next step will be for the FDA to propose adding bemotrizinol to the list of over-the ... "Consumers are purchasing products with bemotrizinol ...
JD Supra14d
GLP-1 Drugs: FDA Removes Lilly’s Zepbound® and Mounjaro® (tirzepatide injection) from its Drug Shortage List
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide ...
Nasdaq14d
Indivior Announces FDA Grants Priority Review For SUBLOCADE Prior Approval Supplement
(INDV) announced that the U.S. Food and Drug Administration has granted Priority Review designation for the Prior Approval Supplement of ... means that the FDA's goal is to take action on an ...
Morningstar27d
Heron Therapeutics Announces FDA Approval of the Prior Approval Supplement Application for ZYNRELEF® Vial Access Needle ("VAN")
today announced that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Prior Approval Supplement Application for ZYNRELEF® (bupivacaine and meloxicam) extended-release ...
Yahoo20d
Iowa City takes steps to ban kratom, citing lack of FDA approval, public health concerns
The FDA has drawn a clear line on kratom, saying that "no drug products containing kratom or its two main chemical components ...
Nasdaq27d
Heron Therapeutics' Zynrelef Vial Access Needle Receives FDA Approval
(RTTNews) - Wednesday, Heron Therapeutics Inc. (HRTX) announced that the FDA has approved the Prior Approval Supplement Application for the Zynrelef Vial Access Needle or VAN. Following this ...
WKRN-TV15d
Indivior's SUBLOCADE® Rapid Induction/Alternative Injection Site Prior Approval Supplement (PAS) Receives FDA Priority Review
the FDA or other regulatory agencies may not agree with our regulatory approval strategies or components of our filings for our products and may not approve, or may delay the approval of ...