Drugs
FDA has cited Medispray Laboratories, a finished drug product manufacturer based in Ponda, Goa, India, for significant lapses in its quality control (QC) procedures following a January inspection at its facility. According to a just-posted Form FDA 483, investigators found that the company’s quality control responsibilities and procedures
Drugs
Intellia Therapeutics is reporting that a patient who experienced liver toxicity after being administered the company’s CRISPR-based therapy nexiguran ziclumeran (nex-z) has died. Late last month, FDA issued a clinical hold on Intellia’s MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nex-z after the company
Drugs
Senate Democrats says they are worried that FDA and HHS may rely on partisan “junk science” during its recently announced review of the existing safety and effectiveness data of the abortion drug mifepristone. In a 11/6 letter to FDA and HHS, the Democrats expressed concern that the administration might
Drugs
FDA has publicly released an 11/4 complete response letter issued to Biohaven on its NDA seeking approval of troriluzole to treat spinocerebellar ataxia (SCA). The quick posting comes just three days after the company received the rejection letter and thoroughly complained about the agency action in an 11/5
Drugs
FDA has extended by three months its review of Rhythm Pharmaceuticals’ supplemental NDA for Imcivree (setmelanotide) and its use in treating acquired hypothalamic obesity. The revised user fee review action target date is 3/20/2026. The review extension is related to an agency request for additional sensitivity analyses of
Drugs
FDA has released the form FDA-483 issued following an 8/19-8/27 inspection at the Baxter Oncology drug manufacturing facility in Halle, Westfalen, Germany. The inspection observations were: * failure to establish process, procedural controls, and testing designed to assure that manufactured drug products have the identity, strength, quality,
Drugs
FDA has published a batch of 32 new and 44 revised draft product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. An agency post has links to each of the new or revised guidances. The batch contains 64 PSGs for products with
Drugs
The Trump Administration has announced new agreements with Eli Lilly and Novo Nordisk to lower U.S. prices for several products, including the GLP-1 medications Ozempic and Wegovy, when purchased through the new TrumpRx drug distribution platform. The agreement is part of the administration’s Most-Favored-Nation (MFN)
Drugs
FDA has awarded six additional vouchers under the Commissioner’s National Priority Voucher pilot program, bringing the number of awards to 15. Upon submission of a complete application, national priority voucher holders are to receive a decision within months, described as a “drastic reduction” of the typical review timeline, contingent
Drugs
FDA has warned 18 Web sites that they are illegally marketing unapproved and misbranded botulinum toxin products, commonly called Botox. An agency notice (contains a link to the Warning Letters) says FDA is aware of adverse events associated with unapproved and misbranded botulinum toxin products, including botulism symptoms. The notice
Drugs
An Obesity Action Coalition (OAC) survey presented during ObesityWeek 2025 shows that people with obesity overwhelmingly expect FDA and drug companies to close critical gaps in how drugs are tested and labeled. An OAC media statement says that although more than 40% of U.S. adults live with obesity, most
Drugs
FDA has approved an expanded use for Johnson & Johnson’s Caplyta (lumateperone) as an adjunctive therapy with oral antidepressants in adults with major depressive disorder. Caplyta was previously approved for schizophrenia and bipolar I and II depression. Approval was based on data from two global, double-blind, placebo-controlled
Drugs
Rep. Abe Hamadeh (R-AZ) is calling on FDA to pause its recent enforcement actions against desiccated thyroid medications in response to allegations made against former CDER director George Tidmarsh (see earlier story). In a statement (contains a link to his letter to FDA commissioner Marty Makary), Hamadeh says he
Drugs
Centessa Pharmaceuticals is reporting encouraging clinical data for its oral OX2R agonist ORX750 in patients with narcolepsy Types 1 and 2 (NT1, NT2) and idiopathic hypersomnia (IH). In a third-quarter financial update, the biotech firm says data from the initial dosing cohorts of its ongoing Phase 2a CRYSTAL-1
Drugs
A 3/25-4/8 FDA inspection at the Liebel-Flarsheim drug manufacturing facility in Raleigh, NC, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 10/17 Warning Letter says the specific violations were: * failure to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has released the form FDA-483 issued following a 5/26-5/31 inspection at the Alembic Pharmaceuticals active pharmaceutical ingredient manufacturing facility in Tal. Halol, Gujarat, India. The four inspection observations were: * failure to conduct timely laboratory investigations or to thoroughly determine the root cause; * failure of laboratory
Drugs
FDA has issued Biohaven a complete response letter, rejecting the company’s NDA for Vyglxia (troriluzole) as a treatment for spinocerebellar ataxia (SCA), a rare and progressive neurodegenerative disease with no approved therapies. The agency letter cited concerns about potential bias and design limitations inherent in the real-world evidence
Drugs
FDA has issued a Warning Letter to Apotex, citing significant GMP violations at the company’s Richmond Hill, Ontario, facility, including failures in sterility assurance, equipment maintenance, and quality investigations. The 10/31 letter follows an inspection conducted from 4/28 to 5/9 at the site, which manufactures sterile
Drugs
A 4/21-5/2 FDA inspection at the Scientific Protein Laboratories drug manufacturing facility in Waunakee, WI, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 10/10 Warning Letter says the specific deviations were: * failure to ensure that equipment surfaces in
Drugs
FDA has approved a Meitheal Pharmaceuticals NDA for Contepo (fosfomycin) for injection for treating adults with complicated urinary tract infections (cUTI), including acute pyelonephritis, caused by susceptible Escherichia coli and Klebsiella pneumoniae. Fosfomycin is described by the company as a novel epoxide antibacterial and the only intravenous antibiotic of its
FDA Policy/General
Reflecting on the recent FDA turmoil over the resignation of CDER director George Tidmarsh, Axios questions how long industry can “tolerate an underperforming and dysfunctional FDA … before looking to other markets.” Tidmarsh resigned as controversy broke over comments he made on social media that were part of a lawsuit alleging
Drugs
Sarepta Therapeutics says its long-running Phase 3 ESSENCE confirmatory study evaluating its Duchenne muscular dystrophy drugs Amondys 45 (casimersen) and Vyondys 53 (golodirsen) showed mixed data, but the company still plans to meet with FDA to discuss converting the therapies from accelerated to traditional approval. The nine-year, placebo-