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
Biologics
Pierre Fabre Pharmaceuticals (PFP) says its tabelecleucel BLA has been resubmitted with a proposed indication as monotherapy for treating adult and pediatric patients 2 years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. PFP resubmitted
FDA Policy/General
FDA says it is recruiting new agency advisory committee members who have scientific or consumer involvement in healthcare. An agency statement says advisory committees “are a cornerstone of FDA’s science-based, transparent regulatory process. These committees and panels bring together scientific experts such as physicians, researchers, biostatisticians, along with
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
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
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
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
Independent news and analysis of FDA regulation, policy and enforcement
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
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
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
DBV Technologies has submitted a BLA for the VIASKIN Peanut Patch in children with a peanut allergy aged 4 through 7 years. The company says it requested a priority review for the submission. The patch uses epicutaneous immunotherapy, which the company describes as an innovative, non-oral, non-injection approach
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
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,
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
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