Drugs
FDA has published a strategy document on facilitating Chemistry, Manufacturing, and Controls (CMC) readiness for products with accelerated clinical development. The document says its publication completes the four CMC items the agency agreed to do under PDUFA 7. The strategy document says FDA: * published a CDER Manual of Policies and
Drugs
Bringing the keynote address at the Society of Cardiovascular Computed Tomography’s annual meeting, former FDA commissioner Rob Califf warned that efforts need to be made if the nation’s overall population health outcomes are to improve. He said the U.S. faces a troubling paradox in which revolutionary advances
Drugs
The Senate HELP Committee has voted unanimously to advance legislation sponsored by Sen. Rand Paul (R-KY) to streamline the biosimilar approval process. A statement issued by Paul says the Expedited Access to Biosimilars Act would increase market competition, lower drug prices, and increase access to more life-saving treatments.
Drugs
FDA has cited SGS France Life Sciences following an 8/2025 inspection, identifying multiple deficiencies involving bioanalytical method validation, study documentation and adherence to standard operating procedures at the company's Saint-Benoît, France, facility. According to a just-posted three-page Form FDA 483, investigators documented four inspectional
Drugs
Lilly says its investigational first-in-class GIP, GLP-1, and glucagon triple hormone receptor agonist retatrutide met its primary endpoint in the Class 3 TRIUMPH-2 and TRIUMPH-3 studies, delivering substantial weight loss in adults with obesity complicated by type 2 diabetes and established cardiovascular disease. The company
Drugs
Advocacy group Public Citizen has filed a petition urging FDA to ban prescription drug direct-to-consumer (DTC) advertising. Such a prohibition would “align U.S. policy with international best practices, protect the public from misleading and harmful drug promotion, and promote rational, evidence-based prescribing,” the group contends. “DTC
Drugs
FDA has accepted for review Revolution Medicines' NDA for daraxonrasib, an investigational oral RAS-targeted therapy for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC), the company announced Wednesday. The submission seeks approval of daraxonrasib for adults with metastatic PDAC who have previously received treatment. The drug is
Drugs
Attorney Megan Robertson (Epstein Becker Green) says the biggest trend in FDA Warning Letters so far this year has been the agency’s crackdown against online telehealth platforms that offer compounded GLP-1 drugs. Appearing in a brief video, Robertson says FDA’s push is for the companies to clean
Drugs
FDA has released the form FDA-483 issued following a 2/9-2/18 inspection at the CSL Behring GmbH licensed biological drug manufacturing facility in Marburg, Hassia, Germany. The four inspection observations were: * failure of the quality control unit to review and approve changes to written procedures; * failure to
Drugs
FDA investigators cited Cliantha Research Ltd, a contract research organization in Ahmedabad, India, over data integrity, documentation and clinical research deficiencies following an inspection conducted 4/13-17. The agency issued a four-page Form FDA 483 to the company documenting six inspectional observations at Cliantha's bioanalytical and
Drugs
FDA acting commissioner Kyle Diamantas says the agency has been taking steps that will boost American jobs while protecting the supply of medicines. Writing in a 7/22 Fox News opinion piece, Diamantas cites the PreCheck Pilot Program and new draft regulations to streamline pathways for distributed manufacturing and provide
Drugs
FDA has approved GSK's Jideytro (zidesamtinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have previously been treated with a ROS1 kinase inhibitor, giving patients with the rare form of lung cancer a new targeted treatment option. The approval came
Drugs
Novo Nordisk has filed a Lanham Act suit in New Jersey federal court alleging that ads for Lilly’s GLP-1 drug Zepbound and Mounjaro (both tirzepatide) are deceptive because they reference outdated studies in an attempt to demonstrate the Lilly products are superior to Novo Nordisk’s Ozempic and
Drugs
A 1/19-1/23 FDA inspection at the Shimoga Chemicals drug manufacturing facility in Sengli, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 7/13 Warning Letter says the specific violations were: * failure to ensure that all specifications, sampling
Drugs
An FDA 3/3-3/7/2025 Bioresearch Monitoring inspection at the Alembic Research Center in Vadodara, Gujarat, India, found the facility did not obtain informed consent for a redacted in vivo bioequivalence study. A 7/10 Warning Letter says it appears Alembic failed to adhere to the applicable statutory
Drugs
FDA has granted Acadia Pharmaceuticals a Fast Track designation for remlifanserin, an investigational, highly selective, 5-HT2A receptor inverse agonist for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). Acadia says enrollment has been complete in the company’s Phase 2 RADIANT study that is evaluating remlifanserin
Drugs
InnoDev Partners consultants Gail McIntyre and Michelle Usher say the biopharma industry could benefit from re-embracing the 505(b)(2) approval pathway under which sponsors may draw on previous findings around an existing drug even as they propose modifications to it. Writing in a BioSpace column, McIntyre and Usher
Drugs
China approved more novel oncology drugs than the U.S. between 2020 and 2025, with its annual approval totals surpassing FDA’s beginning in 2023, according to a new analysis published in Health Affairs Scholar by Friends of Cancer Research. The analysis found that China's National Medical Products
Drugs
A Nevada businessman has pleaded guilty to importing and distributing misbranded prescription erectile dysfunction drugs from India, generating more than $1.9 million in online and retail sales, federal prosecutors say. The case was investigated by FDA's Office of Criminal Investigations and the U.S. Postal Inspection Service.
Drugs
A new study published in JAMA Health Forum suggests the market for compounded GLP-1 weight-loss drugs remains robust despite the FDA's resumption of enforcement against copies of commercially available products following the end of semaglutide and tirzepatide shortages. Researchers conducted a "secret shopper" survey
Drugs
FDA has cited Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, NC, raising concerns about microbial contamination controls, environmental monitoring and investigations into repeated contamination events, according to a Form FDA 483 issued following a March inspection. The inspection came on
Drugs
FDA has accepted for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly. The agency has set a user fee review action target date of 12/18. Last month, FDA issued a second complete response letter (CRL) to the Swedish biotechnology company that was