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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offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for a development program.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
FDA’s expedited regulatory programs cut up to two years off both clinical development and approval times for more than half of the drugs approved from 2015-2022, according to a new study. Read More
The FDA issued Outlook Therapeutics a complete response letter (CRL) on its BLA for Lytenava (bevacizumab), an investigational ophthalmic formulation under development to treat wet age-related macular degeneration (AMD). Read More
Our coverage spans a bone graft product that caused a tuberculosis infection, a subcutaneous cancer treatment, a warning letter for an eye drop manufacturer, 300 higher risk patients with a recalled Medtronic cardiac pump, and a lawsuit by Insulet against a competitor for intellectual property theft. Read More
The FDA is seeking public comment on its decision to withdraw accelerated approval for Oncopeptide’s Pepaxto (melphalan flufenamide), after a required postmarketing study showed that the drug plus dexamethasone failed to improve progression-free survival in patients with relapsed or refractory multiple myeloma. Read More