Drugs
FDA has accepted for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients with advanced small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. If approved, the drug — also known as I-DXd — would become the first therapy
Drugs
FDA has cited Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are “false or misleading” and violate federal law. In a just-posted letter to Pfizer, CDER Office of Prescription Drug Promotion says a series of ads promoting Adcetris misrepresented the drug’s
FDA Policy/General
A new policy analysis from the Cato Institute is calling on FDA to modernize its regulatory framework for artificial intelligence (AI) in healthcare, arguing that current rules are slowing innovation and discouraging companies from developing high-impact medical tools. In the 4/13 blog post, authors Christopher Gardner and Kevin
Drugs
FDA has accepted a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma, and set a user fee review action date of 9/11. A year ago, FDA issued Telix a complete response letter on its NDA , saying it could not be approved in its
Drugs
FDA has cited significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient (API) facility operated by Orchid Pharma Limited in India, following an inspection last year. According to the just-posted 2/18/2025 FDA Form 483, inspectors identified multiple lapses at the company’s plant in Alathur,
Biologics
FDA has issued Replimune a complete response letter (CRL), declining to approve its BLA for vusolimogene oderparepvec in combination with nivolumab for advanced melanoma. In a 4/10 letter, the agency said a reanalysis of clinical data and review of additional evidence failed to demonstrate “substantial evidence of effectiveness” for
Devices
FDA has issued an early alert regarding a potential safety issue affecting certain sizing catheters manufactured by Cook Medical, warning healthcare providers to stop using the devices and return affected products. Sizing catheters are commonly used in angiographic procedures to help clinicians measure and navigate blood vessels. The agency says
FDA Policy/General
Representative Jake Auchincloss (D-MA) is urging FDA whistleblowers to come forward to disclose instances of wrongdoing by agency managers. “FDA Commissioner Marty Makary’s incompetence and poor stewardship are undermining the Food and Drug Administration,” Achincloss says in a video posted on X. “Multiple former senior FDA officials have
FDA Policy/General
The homepage of the consumer Web site for BioCorRx Pharmaceuticals’ Lucemyra (lofexidine) tablets for oral use is false and misleading, according to a 3/27 Untitled Letter issued by the CDER Office of Prescription Drug Promotion (OPDP). The letter says the homepage includes a claim that Lucemyra is the only
Drugs
Vanda Pharmaceuticals says a proposal in the FDA FY 2027 congressional budget justification would eliminate the statutory requirement that the agency must review an NDA within 180 days of filing. “In plain terms,” a company statement says, “this change would extend statutory review times rather than shorten them. It would
Devices
FDA and the medical device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations, according to a MedTech Dive report. Both sides have reached an “agreement in principle” on most elements of the deal and are now working to finalize
Devices
Medline Industries has recalled (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death. The recall affects Namic Angiographic Rotating Adaptor Control Syringes and related convenience kits, which are used to deliver contrast media during imaging procedures. The company has instructed customers to immediately remove
FDA Policy/General
Attorneys Charles Snow and Dara Levy (Hyman, Phelps & McNamara) say a bipartisan effort led by Sens. Richard Durbin (D-IL) and Roger Marshall (R-KS) to push FDA to take a more positive role in early review of prescription drug direct-to-consumer ads, coupled with heightened FDA enforcement
FDA Policy/General
HHS secretary Robert F. Kennedy Jr. has been told by the White House to tone down and curtail his public commentary on vaccines as part of a deliberate political strategy by the Trump administration, according to a newly revealed internal memo reported by Bloomberg. The memo outlines a “low-risk
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a patient brochure for Amneal Pharmaceuticals’ Alymsys (bevacizumab-maly), a biosimilar of Genentech’s Avastin, is false or misleading for multiple reasons. A 3/31 Untitled Letter cites concerns that the brochure: * fails to provide material information about the full FDA-
Drugs
At the 3/10 meeting of the PDUFA 8 reauthorization steering committee, industry responded to FDA’s perspectives on the America First fee incentives proposal. Meeting minutes indicate that the two sides discussed that, contingent on FDA and industry agreeing to eligibility criteria for applications with Phase 1 clinical trials
Drugs
Granules India Ltd is tightening oversight of its manufacturing operations and accelerating digitization efforts based on FDA-documented compliance issues at its largest facility, a company executive told Reuters. FDA cited the drugmaker last year (see story) in a Warning Letter, noting violations related to record-keeping, equipment cleaning, and
FDA Policy/General
FDA has cited significant manufacturing and quality control deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy, following a 2/2025 inspection. The inspection identified lapses in quality unit oversight, including failures to properly document and investigate deviations, inadequate control over testing and inspection
FDA Policy/General
Pharmaceutical direct-to-consumer advertisers should treat a legislative proposal in FDA’s recent budget documents (see earlier story) to curb misleading ads as confirmation that enforcement will intensify under this administration. Under the proposal, FDA seeks authority to deem a drug to be misbranded if a DTC drug advertisement
Drugs
FDA is convening a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for rare diseases. The workshop is part of a broader agency effort to accelerate rare disease drug development under mandates tied to the FDA User Fee Reauthorization Act of
Drugs
Insmed says it will discontinue development of its drug candidate brensocatib for hidradenitis suppurativa (HS) after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints. HS is a chronic, non-contagious inflammatory skin disease characterized by painful lumps (nodules/boils) that form under the skin,
Drugs
Drug companies that operate in both the U.S. and the European Union (EU) should treat supply chain strategy as a core regulatory function and not an afterthought. That’s the key takeaway from attorney Winston Kirton (Baker Hostetler) in a recent Regulatory Horizons podcast on how regulatory practices in