Drugs
CDER has launched a new Office of Innovation and Clinical Trial Modernization (OICTM), including dedicated divisions for artificial intelligence and real-world evidence analytics. The office became operational 10/1 within CDER’s Office of Medical Policy, coinciding with the start of the new federal fiscal year. Its creation was
Drugs
FDA has approved Eli Lilly’s Jaypirca (pirtobrutinib) for treating adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) with no known 17p deletion. Approval was based on data from the BRUIN CLL-313 (NCT05023980) trial in 282 patients with previously untreated CLL/SLL without
Drugs
The FDA has granted fast track status to Trethera’s TRE-515 in combination with KRAS inhibitors for certain patients with KRAS G12C-mutated non-small cell lung cancer (NSCLC). The designation covers TRE-515 combined with KRAS inhibitors for patients with G12C mutation-positive NSCLC previously treated with an
Drugs
FDA has cited Olympia Pharmaceuticals for eight observations involving aseptic processing, environmental monitoring, component testing and other manufacturing controls following an inspection last month at the company's Orlando, FL, outsourcing facility. The Form 483 said Olympia’s aseptic processing areas had deficiencies in environmental and personnel monitoring. Investigators
Drugs
Patient-safety advocate Suzanne B. Robotti is calling for stronger postmarket safety and drug-quality accountability measures to be added to the upcoming reauthorization of the brand and generic drug user fee programs. Writing in an 10/1 MedShadow opinion piece, Robotti said she urged FDA during September public meetings
Drugs
FDA has posted an updated final guidance describing the international technical standard for electronically transmitting individual case safety reports, incorporating technical changes made to the ICH E2B(R3) implementation guide in 2025. The guidance, entitled “E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and
Drugs
FDA has released the Form FDA-483 issued following an 8/20-8/28 inspection at Houston Rx, a Houston, TX, producer of sterile drugs. The 14 inspection observations were: * personnel performed aseptic manipulations with exposed hair or skin; * a pattern of frequent or acute pressure reversals was observed from
Drugs
Eli Lilly says its experimental combination of the amylin agonist EloraTZP (eloralintide and tirzepatide) produced greater weight loss and A1C reductions than high-dose tirzepatide (Lilly’s Zepbound ) alone in a Phase 2b trial of adults with obesity or overweight and Type 2 diabetes, prompting the company to advance the
Drugs
A 3/16-3/27 FDA inspection at Bentley Laboratories, a contract drug manufacturing firm in Edison, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs and other violations. A 9/17 Warning Letter says the specific CGMP violations were: · failure to thoroughly investigate any
Drugs
FDA has released the Form FDA-483 issued following an 8/24-9/8 inspection at Right Value Drug Stores, an Irving, TX outsourcing facility. The six inspection observations were: * failure to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failure of laboratory controls
Drugs
FDA has accepted for priority review a Roche NDA for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The submission is based on data from the Phase 3 FENhance 1 and 2 RMS studies and
Drugs
Aldeyra Therapeutics says it intends to submit a Formal Dispute Resolution Request to FDA, challenging a 3/16 Complete Response Letter that denied approval of the company’s NDA for reproxalap for treating dry eye disease. “Following an NDA submission and two NDA resubmissions of reproxalap for the treatment of
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
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
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
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
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,
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Drugs
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
Drugs
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