Drugs
Disc Medicine says it will resubmit an NDA by year-end for bitopertin in adults and adolescents with erythropoietic protoporphyria (EPP) following just-reported APOLLO Phase 3 favorable data. According to the company, the results demonstrated statistically significant and clinically meaningful benefits across all study endpoints. Earlier this year, FDA
Drugs
Advanced imaging technologies could help generic drug manufacturers overcome longstanding challenges in demonstrating bioequivalence for complex drug products, potentially reducing reliance on costly comparative clinical endpoint studies, according to a new journal article by FDA researchers. Their review, published in a recent issue of Biophotonics Discovery, examines how modern imaging
Drugs
FDA has accepted for review a UroGen Pharma NDA for investigational drug UGN-103 (mitomycin), an intravesical solution for treating adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The agency has set a user fee review action target date of 6/14/2027.
Devices
FDA has cited Australian medical device manufacturer Saluda Medical Pty. Ltd. for deficiencies involving cleanroom controls, manufacturing procedures and adverse event reporting, according to a just-posted Form FDA-483 related to a 5/25 inspection of its facility in Macquarie Park, New South Wales. In the three-observation Form
FDA Policy/General
FDA has issued a final guidance outlining the identity and safety information manufacturers and distributors should include in new dietary ingredient notifications (NDINs) for dietary supplements. The guidance,“New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety Information About the NDI,” finalizes three sections of a 2016 revised
FDA Policy/General
The Trump administration is advancing an interim plan to allow compounding pharmacies to produce certain unapproved peptides despite FDA scientists' findings that available evidence is insufficient to establish their safety and effectiveness. HHS 10/15 submitted an "interim access policy" for peptides to the White House Office
Biologics
FDA should eliminate “redundant biosimilar trials when rigorous scientific evidence already establishes similarity,” a 10/16 Newsweek opinion piece by Sarfaraz K. Niazi says. The commentary argues that advances in analytical testing now allow manufacturers to demonstrate that proposed biosimilars are highly similar to reference biologics without necessarily conducting additional
Drugs
FDA is ramping up oversight of clinical trials conducted outside the U.S., placing greater emphasis on data integrity, GMP compliance and the applicability of foreign study results to American patients, according to an analysis by attorneys at Foley Hoag LLP. In a 10/16 client alert, attorneys Matthew Piscitelli
Devices
CDRH has issued an early alert after learning that Edwards Lifesciences notifed customers recommending certain delivery systems used for SAPIEN M3 transcatheter mitral valve replacement be removed from where they are used or sold. Affected devices: * Commander M delivery systems (for SAPIEN M3 Transcatheter Mitral Valve Replacement System); Lots: 67718561,
Drugs
FDA has approved UCB’s Zilbrysq (zilucoplan), a self-administered once-daily autoinjector administration option for treating generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. The Zilbrysq autoinjector is designed to automatically deliver a pre-defined dose when activated against the skin. Prior to
FDA Policy/General
The Milken Institute is urging the FDA and other federal agencies to overhaul clinical trial policies, arguing that unnecessarily restrictive eligibility criteria, cumbersome consent requirements and fragmented regulatory oversight are limiting patient participation and slowing medical research. In a 10/13 report, Enabling Access to Clinical Research: An Action Plan
FDA Policy/General
Three former FDA commissioners sharply criticized the Trump administration’s staff cuts at FDA over the last year, warning that the loss of experienced scientific and regulatory staff has weakened the agency's institutional knowledge and will take years to reverse. Speaking 10/14 at the 2026 STAT Summit
Drugs
A 10/20-10/30/2025 FDA inspection at SCA Pharmaceuticals’ outsourcing facility in Little Rock, AR, found serious deficiencies in the firm’s practices for producing drug products that are intended or expected to be sterile. A just-released 9/14 Warning Letter says the agency investigator collected evidence
Drugs
Vanda Pharmaceuticals says its development program for VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor partial agonist, is on hold after the therapy failed to meet its primary endpoint in a Phase 3 clinical study in patients with social anxiety. The study, VP-VQW-765-3201 (Study
Drugs
The Antidepressant Coalition for Education is petitioning FDA to require postmarketing studies and a national patient registry for selective serotonin reuptake inhibitors (SSRI) and serotonin-norepinephrine reuptake inhibitors (SNRI). The petition says the patient registry should prospectively follow patients during and after SSRI or SNRI tapering or discontinuation and should
FDA Policy/General
Drugs
FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis. The agency has set a review action target date of 3/16/2027. In January, FDA issued the company a complete response letter (CRL) on the original
FDA Policy/General
Former Sheppard, Mullin life sciences and FDA practice attorneys Scott Liebman and Dominick DiSabatino have joined Mayer Brown as partners in its Life Sciences practice. “They specialize in FDA rules and regulations and further strengthen Mayer Brown's capabilities advising pharmaceutical, biotechnology, medical device, healthcare, and digital health companies
FDA has asked NRx Pharmaceuticals to submit “minor” changes to the submitted label for the company’s preservative-free ketamine product NRX-100. A company statement says NRx was asked to submit sample labeling with the proposed proprietary name currently under review in advance of the 11/10 GDUFA target
FDA Policy/General
The growing use of online prediction markets Kalshi and Polymarket to wager on clinical trial outcomes and FDA drug approvals could compromise trial integrity, encourage insider trading, and undermine public confidence in regulatory decisions, three Boston University researchers warned. Kalshi launched a pilot program in July (see earlier story) allowing
FDA Policy/General
Two federal employee unions have accused FDA of violating employees’ First Amendment rights by prohibiting off-duty union activities and restricting the use of agency computers and networks for union-related communications. In a 10/9 letter to FDA acting commissioner Kyle Diamantas and chief operating officer Melanie Keller, the
Drugs
FDA says it is launching a Rare Disease Framework Initiative “to reimagine the development of drugs and biologics for rare diseases.” In a statement, which includes a link to a new white paper on the initiative, the program will “develop an optimized, fit-for-purpose framework that reflects the realities