Drugs
The U.S. Attorney’s Office for the Middle District of Florida and the Department of Justice’s Criminal Division have announced federal charges against Swapnadip Roy and Vicky Ramancha. The two Indian nationals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution
Drugs
Five FDA drug company 2026 Warning Letters should be studied by other manufacturers who want to learn more about the agency’s position on documentation defensibility, according to a Quality Digest online post. The post says that in each of the five letters, that were issued within seven weeks, a
Drugs
A 1/27-2/18 FDA inspection at the Fresenius Kabi USA drug manufacturing facility in Melrose Park, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/22 Warning Letter says the three specific violations were: * failure to thoroughly investigate any unexplained discrepancy
Drugs
Some 44 members of the congressional Democratic Women’s Caucus have written to FDA acting commissioner Kyle Diamantas and HHS secretary Robert F. Kennedy Jr., asking that they immediately address the ongoing shortage of estradiol transdermal patches that help manage menopause symptoms. A caucus statement (contains a link to the
Drugs
The Senate has approved a House version of Accelerating Access to Critical Therapies for ALS Reauthorization Act of 2026 (HR 8205) by unanimous consent. The bill, which extends the original ACT for ALS programs through fiscal year 2031 to maintain funding and access to investigational treatments, now heads to president
FDA Policy/General
FDA policy analyst and former HHS official Steven Grossman said FDA commissioner nominee Heidi Overton demonstrated at her confirmation hearing that she understands the agency must remain grounded in law, science and established regulatory processes, arguing that she could be a productive commissioner despite the difficult political environment she would
FDA Policy/General
The Pharmaceutical Research and Manufacturers of America (PhRMA) board of directors have selected former House majority leader Eric Cantor as the group’s next president and chief executive officer. Cantor represented Virginia’s 7th Congressional District as a Republican from 2000 to 2014, serving as House Majority Leader from 2011
Drugs
A 1/28-2/5 FDA inspection at the Curia New York drug manufacturing facility in Rensselaer, NY, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A just-released 9/18 Warning Letter says the specific deviations were: * failure to have laboratory control
Drugs
FDA has issued Warning Letters to Neogen Corp. and Sciarra Aeromed Inc. after an investigation linked fungal contamination in a veterinary wound-care product to serious infections in nearly 100 horses and at least 20 deaths. An agency notice says Neogen Vet HYCOAT, a hyaluronate sodium solution labeled as sterile,
Biologics
Daiichi Sankyo and Merck have withdrawn a BLA seeking accelerated approval for ifinatamab deruxtecan (I-DXd) for treating adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The action was based on input from FDA indicating that “data supporting
Independent news and analysis of FDA regulation, policy and enforcement
FDA is maintaining a clinical hold preventing enrollment of new U.S. patients in Newron Pharmaceuticals’ Phase 3 ENIGMA-TRS 2 study of evenamide for treatment-resistant schizophrenia. Newron says it expects written communication from the agency providing additional information on the decision and identifying any further protocol changes that
FDA is making approval of generic GLP-1 drugs a priority as it seeks to increase competition and reduce the cost of the increasingly widely used medicines, CDER director Michael Davis told a recent FDA meeting, according to a report by the Regulatory Affairs Professionals Society (RAPS). Speaking at a
Chugai Pharmaceutical is preparing to revive emugrobart’s (GYM329) development for spinal muscular atrophy (SMA) just six months after Roche abandoned the program, citing new consideration of long-term clinical signals and modifications to a potential Phase 3 trial design. The reversal comes as Roche decided to discontinue a separate
The National Institutes of Health has awarded $19.4 million for a five-year international research project aimed at developing a blood test that could determine whether Alzheimer’s disease has progressed far along to explain a patient’s cognitive symptoms and help predict future disease progression. The project, led
EBR Systems says FDA issued a Form 483 with two observations following an inspection of the company’s new manufacturing facility in Santa Clara, CA. The inspection is related to the agency’s review of a PMA supplement seeking to add the site as a manufacturing facility for its WiSE
FDA’s Office of Global Policy and Strategy principal advisor Ravi Bharwani has been promoted to OGPS deputy director. Since 2021, he served as principal policy advisor in OGPS’ immediate office (IO) leading stakeholder or counterpart engagements and coordination, advising the associate commissioner on complex issues, and managing IO functions,
FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’
FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few
FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued
FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing
FDA has accepted for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) for treating patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. The agency set a user fee review action target date for upcoming