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Citing deficiencies in the Chemistry, Manufacturing, and Controls (CMC) processes, FDA handed Swiss drugmaker Galderma a complete response letter for RelabotulinumtoxinA, the company’s cosmetic neurotoxin intended to treat frown lines and crow’s feet. Read More
Despite strong testimony and comments from patients and clinicians, the FDA advisory committee reviewing NurOwn, an investigational treatment for amyotrophic lateral sclerosis (ALS), voted against recommending the drug, citing a lack of consistent data and ill-defined biomarkers. Read More
This European Edition of Quick Notes includes guidelines from WHO for pharmaceutical quality control laboratories, UK launch of the Innovative Devices Access Pathway pilot, European Commission (EC) unannounced antitrust inspections at a medical device company and an open letter to the EC about MDR and IVDR. Read More
Eli Lilly and Boehringer Ingelheim have secured another FDA approval for blockbuster diabetes drug Jardiance (empagliflozin), announcing that the agency has OK’d the drug for treating adults with chronic kidney disease. Read More
Despite positive and sometimes emotional testimony from diabetes patients, an FDA advisory committee voted Thursday to uphold CDER’s recommendation that the new drug application for ITCA 650 (exenatide in DUROS device), Intarcia Therapeutics’s diabetes drug/device combo, be denied approval. Read More
ARS Pharmaceuticals announced that the FDA issued a complete response letter (CRL) on its NDA for neffy (epinephrine nasal spray) after having received a recommendation for approval from the agency’s Pulmonary-Allergy Drugs Advisory Committee in May. Read More
The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program. Read More
GSK’s Ojjaara (momelotinib), the first and only treatment for myelofibrosis patients with anemia regardless of prior myelofibrosis therapy, received FDA approval on Friday. Read More
New FDA drug approvals in August include the first ever oral pill to treat postpartum depression, treatments for two ultra-rare diseases and the first vaccine for use in pregnant women to prevent respiratory syncytial virus (RSV) in infants. Read More