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
Devices
A new citizen petition is urging FDA to establish a regulatory framework for implantable brain-computer interfaces (BCIs) designed to expand human sensory perception beyond the natural limits of human vision. The just-posted petition, filed by Ali Afshar of Age Reversal Unity in New York, asks FDA to develop
FDA Policy/General
FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate efforts to fill the agency's top post, according to an analysis published Wednesday by PharmaVoice. More than two months have passed since former FDA commissioner Marty Makary resigned, and the Trump administration
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
Devices
FDA has selected Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking the launch of a joint FDA-CMS initiative designed to evaluate digital health technologies using real-world evidence while expanding access to innovative care for patients with
FDA Policy/General
One of the FDA items in the HHS recently published Unified Agenda would, if finalized, fundamentally reshape the landscape of prescription drug marketing in the U.S. Sheppard attorneys Dominic DiSabatino and Audrey Mercer write in their firm’s FDA Law Update that under the proposed rule, drug manufacturers would
Devices
FDA and medical device industry representatives have reached an agreement in principle on MDUFA 6 and have turned to writing the draft commitment letter to operationalize the agreement. Attorney Jake Leys (Gardner) writes in an online post that the agreement will cover the 2028-2032 fiscal years (see performance goals)
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
FDA Policy/General
To be successful, FDA reform should involve a whole-of-system strategy centered on predictable, inflation-adjusted funding, protection of workforce memory, and renewed engagement with global regulatory and public health networks. That’s the view of a Cureus Journal of Medical Science editorial written by Arya Babul and Parisa
FDA Policy/General
The U.S. House of Representatives has passed the FDA Modernization Act 3.0 (H.R. 2821), advancing bipartisan legislation intended to accelerate the adoption of non-animal testing methods in drug development and align the agency’s regulations with changes Congress enacted four years ago. The bill, sponsored by
FDA Policy/General
FDA has issued an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respiratory syncytial virus (RSV) prevention product Beyfortus (nirsevimab-alip) were false or misleading because they overstated the drug's approved indication. In the letter, CDER’s Office of Prescription Drug Promotion (OPDP)
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
Biologics
FDA has accepted for priority review a Dyne Therapeutics BLA for zeleciment rostudirsen for treating individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The company says it has requested accelerated approval based on dystrophin as a surrogate endpoint. The agency set a user fee review action target
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.