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Minimizing the number of assessment cycles and communications to get to approval is the goal of an FDA draft guidance on the composition statements needed for NDAs and ANDAs. Read More
In this edition of Quick Notes, the FDA finally OKs a 40-year-old European mainstay antibiotic for uncomplicated UTIs, an immunotherapy for bladder cancer, a generic form of Narcan nasal spray, and a pediatric version of Lutahera — the first-ever radioligand approved for use in children. Read More
Investigators found that the FDA OK’d nearly 80 percent of these non-supported surrogate markers as appropriate endpoints for a traditional approval. Read More
Almost 60 percent of surrogate markers supporting FDA approvals for nononcologic drugs for chronic diseases aren’t backed up by meta-analyses showing a strong association between the marker and relevant clinical endpoints, a new JAMA Network study says. Read More
Most cancer drugs that gain an Accelerated Approval don’t end up showing any clinical benefit in their confirmatory trials, exposing thousands of patients to ineffective therapeutics that may linger on the market for years until postmarketing studies show their true clinical impact, a new analysis has shown. Read More
Supernus Pharmaceuticals and IntelGenx have recently received Complete Response Letters (CRL) from the FDA requesting additional quality information on their drug-device combination products. Read More
In this edition of Quick Notes, Vanda gets a new indication for its antipsychotic drug, Daiichi Sankyo and AstraZeneca get a new indication for their oncology drug, multiple myeloma patients can look to earlier use of drugs from Johnson & Johnson and Bristol Myers Squibb, and HHS funds support a new antibiotic approved for three serious infections. Read More
Seeking to get back on track for FDA approval of its first-of-a-kind epinephrine nasal spray, ARS Pharmaceuticals says it has provided the agency with responses to all its additional requests in the Complete Response Letter (CRL) the agency send ARS last September. Read More
This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary arterial hypertension, a new drug to treat a pediatric metabolic disorder and an IV maintenance drug for patients with early Alzheimer’s disease. Read More