Drugs
The staff of the online newsletter Global Biodefense raises a concern that FDA’s recent action stopping clinical trials that involve shipping participants’ biological samples to laboratories in China and other “hostile” countries can cripple biomedical innovation and progress in the U.S. “The stated concern is that overseas sample
Drugs
FDA has granted Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed or refractory (R/R) acute myeloid leukemia (AML) with mutant NPM1 (mNPM1) — the most common genetic alteration found in adult AML patients. The agency has set a 10/25 user
Drugs
Nektar Therapeutics is reporting promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for patients with moderate-to-severe atopic dermatitis. The therapy met all primary and key secondary endpoints in a 16-week analysis of the global Phase 2b REZOLVE-AD study, it says. The
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Usona Institute chief medical officer Michael C. Davis is returning to CDER as the Center’s deputy director after being gone two and a half years, according to several media reports. He left the agency 12/2022 after serving almost seven years as a clinical team leader in CDER’s
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University of Pennsylvania Perelman School of Medicine associate professor of medical ethics and law Holly Lynch says the new FDA Commissioner’s National Priority Voucher (CNPV) program raises the question of how fast is too fast for FDA drug review. Writing online for MedPageToday, Lynch says a deeper look at
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The U.S. House Appropriations Committee 6/24 advanced in a 35 to 27 vote FDA’s fiscal year 2026 spending bill. The bill is in line with the Trump Administration’s budget proposal that would decrease agency spending by 4% ($271 million) to $6.8 billion. This includes $3.
Drugs
FDA has issued a safety communication about two reports of fatal acute liver failure following treatment of non-ambulatory pediatric male Duchenne Muscular Dystrophy patients with Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec-rokl), an adeno-associated virus vector-based gene therapy. The safety alert comes after the company said last week
Drugs
An FDA review of records submitted by Pushclean Technology Plastik Sanayi Ve Ticaret Ltd. Sirketi in Istanbul, Turkey, in response to an agency 9/4/2024 request, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs in the firm’s manufacturing of over-the-counter drug
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CDER acting director Jacqueline Corrigan-Curay has decided to retire and will leave her post next month. After almost nine years at the agency, Corrigan-Curay said in an email to staff that her “incredibly challenging” decision was made more difficult by the fondness she has developed for advancing public
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New data from a Phase 2 study on Eli Lilly’s experimental bimagrumab showed that when combined with Novo Nordisk's Wegovy (semaglutide) it led to preservation of muscle mass while achieving significant weight loss. The data were presented 6/23 at an American Diabetes Association scientific session in
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Medline Industries is recalling (Class 1 device correction) certain lots of its medical procedure kits that include recalled Medtronic Aortic Root Cannulas due to a potential safety risk that could result in serious adverse health outcomes, including stroke or death. The cannulas, a critical component used during heart surgeries involving
Drugs
FDA has released an International Council for Harmonization (ICH) draft guideline entitled “Stability Testing of Drug Substances and Drug Products Q1.” The document outlines stability data expectations for drug substances and drug products, and includes recommendations on how science- and risk-based principles may be applied. It notes that principles
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A new study is contradicting previous assumptions about the relationship between regulatory scrutiny and drug shortages in the U.S. pharmaceutical supply chain. Researchers from the University of Illinois’ Gies College of Business have found that GMP deficiencies cited in FDA inspections are associated with fewer future drug shortages, not
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FDA has approved a Daiichi Sankyo BLA for Datroway (datopotamab deruxtecan-dlnk) for adults with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who have received prior EGFR-directed therapy and platinum-based chemotherapy. The drug was granted accelerated approval based on data
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FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) for treating adult patients with bullous pemphigoid (BP), which the companies say is characterized by intense itch, painful blisters, and lesions, as well as reddening of the skin. Approval is based on data from the pivotal ADEPT Phase 2/3 study
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FDA has approved Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide and rituximab for treating adults with relapsed or refractory follicular lymphoma (FL). Approval is based on data from the inMIND clinical trial, a double-blind, placebo-controlled study involving 548 patients with relapsed or refractory FL, according to
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FDA has approved a Cycle Pharmaceuticals NDA for Harliku (nitisinone) tablets for reducing urine homogentisic acid (HGA) in adult patients with alkaptonuria (AKU), an ultra-rare genetic metabolic disorder in which patients have a buildup of HGA that leads to osteoarthritis, ochronosis, and complications in the kidneys and heart. Approval
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Bavarian Nordic says it has entered into an agreement with an undisclosed buyer to sell for $160 million a priority review voucher that was awarded for gaining approval of its chikungunya vaccine Vimkunya (see earlier story). Under a license agreement when the company acquired the rights to the vaccine in
Drugs
A Texas federal judge has upheld FDA’s action in removing Novo Nordisk’s Ozempic and Wegovy (both semaglutide) from its drug shortage list. CNBC reports the decision is a blow to compounding pharmacies that had been allowed to produce hundreds of thousands of doses of copies of the obesity
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FDA is warning that Baxter Healthcare’s antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature and cause heat-related complications, resulting in hospitalization or even death. An agency safety alert says that most cases occurred in children 17 years and younger and in adults 60 years and
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FDA has approved Gilead’s Yeztugo (lenacapair), an injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis to reduce the risk of sexually acquired HIV in some adults and adolescents. A company statement says Yeztugo is the only twice-yearly option available in the U.S. for people who need
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FDA has published a guidance, Post-Warning Letter Meetings Under GDUFA, with information on the implementation of the post-Warning Letter meeting process for certain facilities as covered in the GDUFA 3 commitment letter. The document says a post-Warning Letter meeting is a meeting with FDA about the facility’