Drugs
FDA says the Yangzhou Hongshengding Chemical Co. in Guangling District, Yangzhou, China, is registered with FDA as a manufacturer of over-the-counter drug products and did not respond to several requests for records and other information relating to its operations. A just-released 6/15 Warning Letter says the
Biologics
CBER has published a Standard Operating Policy and Procedure (SOPP) to guide staff in implementing and maintaining Risk Evaluation and Mitigation Strategies (REMS). The document says the SOPP applies to an initial REMS as part of an original BLA or NDA, or a new REMS needed as part of an
Drugs
FDA approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consistent with recent years despite an unusually turbulent period marked by leadership turnover, high-profile regulatory disputes and policy changes under the Trump administration. According to FDA's novel drug approvals
Drugs
FDA has issued Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging. The company says the letter is requesting additional clinical data and product documentation. “We seek to understand the issues in detail and plan to request a Type A meeting with
Devices
A 12/1-10/10/2025 FDA inspection at 3B Medical, doing business as Reach Health, in Dublin, OH, established that BMC Medical in Beijing, China, is the specification developer and 510(k) owner of various ventilator devices that are imported into the U.S. A just-released 5/20
Drugs
FDA has approved a supplemental indication for Vertex Pharmaceuticals’ Casgevy (exagamglogene autotemcel) for patients aged 2 and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). An agency notice says it’s the first gene therapy approved for patients aged
Devices
A 12/1-12/10/2025 FDA inspection at 3B Medical, doing business as Reach Health in Dublin, OH, found multiple violations in the firm’s manufacturing of iCodeConnect, a cloud-based software device used with continuous positive airway pressure and auto-adjusting positive airway pressure ventilator devices. A just-
Devices
A 11/9-12/3/2025 FDA inspection at AseptiKits in North Salt Lake, UT, found that the company manufactures and markets several PALA Your Tears models. A just-released 6/4 Warning Letter says the firm’s PALA Your Tears models are adulterated because the firm does not have
Drugs
FDA has approved PharmaEssentia’s BESREMi Pen (ropeginterferon alfa-2b-njft) for polycythemia vera (PV). A company statement says PharmaEssentia plans to submit a sBLA to FDA seeking a broader indication to include essential thrombocythemia. FDA previously granted an orphan drug designation for BESREMi to treat PV in adults.
Drugs
A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of the agency's most serious inspection classification than Indian plants in 2025, marking a reversal from a decade ago. The analysis, authored by Anil Kumar Angrish of the National
Biologics
FDA has told Capricor Therapeutics that it has scheduled a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee to review the company's BLA resubmission for deramiocel, an investigational cell therapy for treating Duchenne muscular dystrophy. The panel will meet on 7/29, less than a month
Drugs
FDA has issued Dr. Reddy's Laboratories a seven-observation Form 483 following a recent pre-license inspection of its biologics manufacturing facility in Bachupally, Hyderabad, India. The inspection was conducted from 6/16 to 6/25 as part of FDA's review of the facility ahead of
Drugs
FDA has issued Lantheus a Complete Response Letter (CRL) for its NDA seeking approval for LNTH-2501 (gallium-68 edotreotide), a positron emission tomography (PET) imaging agent for detecting neuroendocrine tumors (NETs). According to the company, the agency letter said it could not approve the application until inspection-related deficiencies
FDA Policy/General
Three candidates have emerged as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection process. Axios reported that Heidi Overton, deputy director of the White House Domestic Policy Council; Jeffrey Vacirca, chief executive officer of New York Cancer & Blood Specialists;
Drugs
FDA has issued Sobi a Complete Response Letter (CRL) on its BLA that is seeking approval of NASP (nanoencapsulated sirolimus plus pegadricase) for treating adults with uncontrolled gout. The letter cited manufacturing-related deficiencies that must be corrected. The company said FDA requested additional information primarily related to the chemistry,
Biologics
The European Commission has opened a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misleading campaign against a rival influenza vaccine marketed by CSL Seqirus. The investigation centers on Sanofi's promotion of its enhanced influenza vaccine, Efluelda, which competes in Europe
FDA Policy/General
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 6. The next overnight email news bulletin from this site will be issued that evening.
Biologics
FDA has accepted for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolumab for treating advanced melanoma, the company announced Friday. The agency classified the filing as a Class 1 resubmission and set a review action target date of 8/
Drugs
FDA has issued an untitled letter to Pinnacle Biologics, alleging that promotional videos for the company's cancer therapy Photofrin (porfimer sodium) contain false and misleading claims that misbrand the product under the Federal Food, Drug, and Cosmetic Act. The CDER Office of Prescription Drug Promotion (OPDP) letter focuses
Drugs
FDA has approved Gilead Sciences' antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) for first-line treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC), significantly expanding the drug's role in one of the most aggressive forms of breast cancer. The approval
Devices
FDA says that based on its data analyses, it has determined that CCIC Huatongwei International Inspection (Suzhou) Co., Ltd., in Suzhou, Jiangsu Province, China, has, in several instances, copied the results of another study or created falsified or otherwise invalid medical device data that were submitted to the agency. “Until
FDA Policy/General
Speaking at the BIO 2026 convention, a panel of former FDA regulators praised the agency’s announcement of a pending IND pilot program as the potential start of a return to normalcy in policy making. The fact that the pilot was announced in an agency statement and solicited stakeholder feedback