Drugs
Consulting firm NSF says that how a company responds to a form FDA-483 can influence how inspection findings are classified and what steps the agency might take in the future. The firm uses an online post (includes a link to the webinar) to present the lessons learned from a
Drugs
An 11/28-12/4/2025 FDA inspection at the Alchymars ICM SM Private Limited drug manufacturing facility in Alathur, Tamil Nadu, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 5/21 Warning Letter says the specific violations were: * failure to
Drugs
An 11/13-11/21/2025 FDA inspection at the Sato Pharmaceutical drug manufacturing facility in Tokyo, Japan, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 5/18 Warning Letter says the specific violations were: * failure to establish and follow appropriate written procedures that
Drugs
The U.S. government has urged the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whether federal drug law preempts state-law claims challenging the sale of compounded medications. In a brief filed 5/21 at the invitation of the justices,
Drugs
Outlook Therapeutics has won an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path toward U.S. approval of the investigational wet age-related macular degeneration treatment. The agency granted the company’s appeal following a Formal Dispute Resolution process with the agency’
Drugs
FDA has cited major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pharmaceuticals, including repeated stability failures tied to a drug product distributed in the U.S. and allegations that electronic batch records were altered without proper documentation. The findings were detailed in a
Drugs
Dyne Therapeutics has submitted a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy (DMD) therapy z-rostudirsen for patients amenable to exon 51 skipping. The submission is based on data from the registrational expansion cohort of the Phase 1/2 DELIVER study, in which the therapy demonstrated
FDA Policy/General
The long-term impact of the Supreme Court’s Loper Bright decision in the health landscape remains unclear, according to an article in the Yale Journal on Regulation. Immediately after the decision was announced, many commentators warned of a coming “seismic” impact. Written by staff and a student at the
Drugs
Biogen and Denali Therapeutics say they will limit the development of their experimental Parkinson’s disease drug BIIB122 after the therapy failed to meet primary and secondary endpoints in a Phase 2b clinical trial. The companies reported that the LUMA study showed BIIB122, also known as DNL151, did not slow
Drugs
FDA has approved Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy, expanding treatment options for patients with one of the most aggressive forms of breast cancer. The drug was
Drugs
FDA has granted Gilead Sciences an accelerated approval for Hepcludex (bulevirtide-gmod) for treating chronic hepatitis delta virus (HDV) infection, marking the first FDA-approved therapy for the rare but potentially life-threatening liver disease. The approval covers treatment in adults with chronic hepatitis delta virus infection who do not
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on general considerations for using new approach methodologies (NAMs) in drug development “marks an important step toward establishing a flexible science-based framework for integrating NAMs into drug development.” The BIO comment letter highlights areas where the association believes additional
Drugs
FDA has published the International Council for Harmonization (ICH) M11 Template: Clinical Electronic Structured Harmonized Protocol, which is intended for interventional clinical trial protocols and is said to be suitable for all phases and therapeutic areas of clinical research. The document is marked “For Reference Only.” It says that existing
Drugs
In response to an FDA request for comments on increasing access to non-prescription drugs, Pharmaceutical Research and Manufacturers of America (PhRMA) says it commends the agency’s commitment to expanding the appropriate availability of non-prescription drugs. “While PhRMA is aligned with the goal of increasing access to non-
Drugs
Eli Lilly says its investigational obesity drug retatrutide produced weight-loss results approaching those historically associated with bariatric surgery in a pivotal Phase 3 clinical trial, strengthening the company’s position in the increasingly competitive obesity treatment market. The drug met all primary and key secondary endpoints in the TRIUMPH-
Drugs
A 3/17-3/20/2025 FDA Bioresearch Monitoring Program inspection of a clinical trial conducted by Dr. Sourav Mishra at the All India Institute of Medical Sciences in Bhubaneswar, Odisha, India, found that the clinical investigation failed to meet statutory and regulatory requirements for the conduct of clinical investigations
Drugs
A 2/14-3/13/2025 FDA Bioresearch Monitoring Program inspection at a clinical site operated by cardiologist Naseem Jaffrani in Alexandria, LA, found he did not follow statutory requirements and regulations governing the conduct of clinical investigations and the protection of human subjects. A 5/4 Warning Letter says
Drugs
FDA has published a guidance, Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations, with recommendations for sponsors planning to conduct food effect studies for orally administered drug products as part of INDs or NDAs and supplements to those applications. The document revises part of
Drugs
Reps. Eric Sorensen (D-IL) and Stephanie Bice (R-OK) have introduced the Stop Games Act, which they say would crack down on tactics used by drug companies to block cheaper generic drugs from entering the market. A statement issued by Sorensen’s office says the bill would crack down
Drugs
An FDA review of records it requested from Hangzhou Yiqi Biotechnology Co., an active pharmaceutical ingredient manufacturer in Hangzhou, Zhejiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 4/15 Warning Letter says the specific deviations were: * failure to
Drugs
An 11/3-11/7/2025 FDA inspection at the Harbin Jixianglong Biotech Co. active pharmaceutical ingredient (API) manufacturing facility in Harbin, Heilongjiang, China, found significant deviations from current good manufacturing practice (CGMP) regulations for APIs. A 5/1 Warning Letter says the four specific deviations were: * failure of the
Drugs
FDA has granted Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the risk of recurrent stroke in patients who have experienced a non-cardioembolic ischemic stroke or transient ischemic attack. The submission is based on data from the Phase 3