Drugs
FDA has accepted for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1 (STGD1). The agency has set a user fee review action target date of 2/12/2027. The submission was based on data from the Phase 3 DRAGON trial, which demonstrated a statistically
Drugs
An 8/4 petition submitted by a Matthew Arp (no affiliation or organization listed) asks FDA to create a continuation access pathway, not unrestricted shelf access, for adults with a prior albuterol sulfate inhalation aerosol prescription or clinician-diagnosed airway disease. The petition says the nonprescription product would remain subject
Drugs
President Trump has signed an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recommendations," reducing the number of diseases for which routine childhood immunization is recommended and giving parents more flexibility in vaccination decisions. The order calls for routine
Drugs
Tenax Therapeutics is reporting that its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction. In the LEVEL trial, TNX-103 did not meet statistical significance on
Drugs
FDA has issued ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its NDA for ¹⁷⁷Lu-edotreotide (ITM-11), an investigational radiopharmaceutical for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The agency letter says the submission could not be approved in its current form due to chemistry, manufacturing and controls
Drugs
Abiomed and manufacturing partner Oscor have issued a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after identifying a potential for leakage that could result in serious bleeding, according to an FDA notice. The introducers are intended to provide access for introducing catheters into the
Drugs
Sarah Ibrahim has been appointed CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January. In this role, Ibrahim serves on CDER’s senior leadership team and supports the Center director by providing executive leadership on strategic initiatives that advance CDER’
FDA Policy/General
The Trump administration is considering an executive order addressing vaccines and autism as soon as next week, according to people familiar with the discussions, potentially launching new federal research into whether vaccines play a role in autism despite extensive scientific evidence finding no causal link. The options under consideration include
Drugs
Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) have introduced the bipartisan Prescription Information Modernization Act to allow drug makers to distribute prescribing information electronically while retaining the option to receive paper copies. Current laws require prescribing information — including dosing instructions, drug interactions, precautions for pregnant women, pediatric
Devices
FDA is announcing a 9/23 meeting of its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee to vote on a Grail PMA for the Galleri test. The test is described as a prescription-only qualitative, next-generation sequencing-based in vitro diagnostic test intended to detect
Drugs
Primus Pharmaceuticals has resubmitted a petition to FDA seeking specific actions on ANDAs for a generic form of the company’s Impoyz (clobetasol propionate) 0.025% topical cream, which is indicated for moderate to severe plaque psoriasis. The petition notes the petition was originally submitted in 2020 by Encore Dermatology,
Drugs
FDA has cited Emcure Pharmaceuticals' sterile injectable manufacturing facility in Ahmedabad, India, for multiple GMP deficiencies following an inspection conducted in May, according to a just-posted Form 483. The nine-page inspection report contains seven observations covering equipment qualification, complaint investigations, laboratory controls, aseptic processing, contamination controls and
Drugs
FDA is asking small dispensers under the Drug Supply Chain Security Act to complete an assessment that will evaluate their ability to conduct interoperable tracing of product at the package level. An agency announcement (contains a link to the assessment) says FDA encourages dispensers with 25 or fewer full-time
Drugs
Eight House Democrats are asking FDA to address estrogen patch shortages for menopause treatment. The seven — Reps. Debbie Dingell (D-MI), Deborah Ross (D-NC), Eleanor Holmes Norton (D-DC), Andrea Salinas (D-OR), Jesus Garcia (D-IL), Yvette Clark (D-NY), Rashida Tlaib (D-MI), and Emily Randall (D-
Biologics
FDA has approved a Moderna BLA for mFLUSIVA (mRNA-1010), a new influenza vaccine for use in all adults 50 years and older. The approval follows a June Vaccines and Related Biological Products Advisory Committee meeting that supported the vaccine’s approval. "The FDA approval of mFLUSIVA, our fourth
Drugs
FDA appears to be signaling that increased regulatory oversight might be on the horizon for unapproved animal-derived thyroid medications, which are used by an estimated 1.5 million Americans to treat hypothyroidism. The agency says it plans to issue new draft guidance outlining its enforcement priorities for such products.
Drugs
A 59% surge in FDA drug Warning Letters in 2025 over 2024 is not the result of isolated mistakes but rather “is the predictable outcome of a structural problem the industry has tolerated for too long.” That’s the view of Krieger Scientific founder and CEO Joseph Morwald, as expressed
Devices
AdvaMed says it strongly supports the draft MDUFA 6 agreement. Speaking at an FDA public hearing, association executive vice president for digital and diagnostics technologies Zach Rothstein said the commitment “builds on what is working, makes practical improvements where they are needed, and prepares the program for the technologies FDA
Biologics
FDA has granted accelerated approval to Replimune for its Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy, in combination with Bristol Myers Squibb's Opdivo (nivolumab), for treating adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1 (PD-1)
Devices
The International Medical Device Regulators Forum (IMDRF), of which FDA is a founding member, has published a final document outlining global principles for Predetermined Change Control Plans (PCCPs), a regulatory approach intended to streamline updates to medical device software while maintaining safety and regulatory oversight. The “Essential Principles and Content
Drugs
FDA has accepted for review a Merck supplemental BLA for Enflonsia (clesrovimab-cfor) to expand its indication to include preventing respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in children under age two years at increased risk for severe RSV disease through their second RSV season. The agency has
Drugs
Two senior U.S. senators are seeking answers from FDA about its plans to address ongoing shortages of several critical chemotherapy drugs. In an 8/5 letter to FDA acting commissioner Kyle Diamantas, Sens. Rick Scott (R-FL) and Kirsten Gillibrand (D-NY) requested a briefing by 9/4 on