Drugs
FDA has approved AstraZeneca's AKT inhibitor Truqap (capivasertib) in combination with abiraterone and prednisone for adults with PTEN-deficient metastatic androgen pathway modulation-naïve or -sensitive prostate cancer, expanding the drug's reach into an earlier-stage prostate cancer setting and marking the first biomarker-directed approval
Drugs
FDA has released a draft guidance to assist NDA sponsors in properly submitting patent information for listing in the agency's Orange Book, providing answers to common questions surrounding the use of Forms FDA 3542 and FDA 3542a. The draft, “Forms FDA 3542a and FDA 3542: Questions and Answers”
Drugs
FDA has approved Merck's Welireg (belzutifan) in combination with Keytruda (pembrolizumab) as an adjuvant treatment for certain patients with renal cell carcinoma (RCC) at elevated risk of disease recurrence following surgery. The approval expands the use of belzutifan beyond its existing indications and establishes a new adjuvant treatment
Drugs
FDA is likely headed toward a rare public hearing that will contest its proposal to withdraw approval of Amgen's ANCA-associated vasculitis drug Tavneos (see earlier story), with the company arguing that the agency's case rests on disputed facts and that patients could lose an important
FDA Policy/General
Some 17 Senate Democrats have written to HHS secretary Robert F. Kennedy Jr. questioning many of his actions and decisions involving FDA and other health-related agencies that the senators say have “decimated our nation’s public health infrastructure and ability to quickly identify and respond to infectious disease outbreaks.
Drugs
Takeda says its zasocitinib significantly outperformed Bristol Myers Squibb’s Sotyktu (deucravacitinib) in the LATITUDE Atlas Phase 3 head-to-head psoriasis study. A Takeda statement says that more than 35% of zasocitinib-treated patients achieved complete skin clearance at week 16, more than 2.5 times the Sotyktu response
Drugs
An FDA review of records it requested 9/ 8/2025 from Port Jervis Laboratories, a manufacturer of over-the-counter drugs in Port Jervis, NY, documented violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 6/2 Notice of Violation says the specific violations were: * failure to
Devices
CDRH associate director for compliance and quality Keisha Thomas told the RAPS Quality Conference that medical device companies need to treat risk management as an ever-evolving responsibility. Her presentation covered FDA’s new compliance program under the new Quality Management System Regulation, according to a RAPS online post. “Our
Drugs
A new Congressional Research Service (CRS) report outlines FDA’s evolving approach to regulating artificial intelligence (AI)-enabled medical devices and highlights ongoing debate over whether the agency's existing authorities are sufficient to oversee rapidly advancing AI technologies. The 6/10 report comes as AI applications become increasingly
Devices
FDA has issued an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System, a positive pressure therapy device used to mobilize lung secretions and deliver aerosolized medications. According to the agency, Baxter has initiated an urgent medical device correction involving
FDA Policy/General
FDA has issued Felix Pharmaceuticals an Emergency Use Authorization (EUA) for generic nitenpyram tablets to treat New World screwworm (NWS) infestations in dogs and cats, marking the first generic animal drug authorized for use against the parasitic pest. The authorization covers over-the-counter nitenpyram tablets for dogs, puppies, cats
Drugs
FDA has issued a second complete response letter (CRL) to Swedish biotechnology company Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection under review for the treatment of acromegaly. The agency's decision was tied to manufacturing-related observations identified during a 2024 GMP inspection of a
Drugs
A Florida federal grand jury has indicted a Pines Care Research Center doctor and two staff members for their roles in an alleged scheme to falsify data in clinical trials of prospective new drug treatments. A Department of Justice news release says Dr. Jaynier Moya of Southwest Ranches, FL, co-
Drugs
FDA has approved changes to the Drug Facts label of Haleon’s over-the-counter weight loss drug alli (orlistat) to warn of the risk of acute kidney injury, which the agency says is a rare side effect of the drug. An FDA statement says the new labeling advises consumers
Drugs
The United States Pharmacopoeia (USP) says the number of drug shortages declined in 2025, but those that did occur lasted longer. The USP 2025 Annual Drug Shortage Report says shortages begin and persist due mainly to four identified risk factors: low price, manufacturing complexity, geographic concentration of manufacturing, and quality
Drugs
A Windels Marx 5/29 petition asks FDA to ensure that any ANDA for dabrafenib mesylate capsules at the 150 mg (EQ Base) strength is supported by appropriate in vivo data and is therapeutically equivalent to Novartis’ cancer drug Tafinlar (dabrafenib). The petition specifically asks that FDA refrain from approving
Drugs
A Health Affairs article says an FDA draft guidance on a “plausible mechanism” framework for approving treatments for patients with individualized genetic disorders needs further clarification. The article notes that an earlier piece praised the draft and proposed ways it could be improved when finalized. It says additional issues to
Drugs
Three Akin Gump attorneys say that while a 2026 FDA draft guidance on how drug companies may communicate healthcare economic information with payors, formulary committees, and similar entities doesn’t break significant new ground, there are some differences between it and the 2018 final guidance it will replace when it
Drugs
FDA is extending the comment period by 30 days for its request for information on drug repurposing for unmet medical needs. Under the initiative, the agency is seeking to identify potential new uses — such as a new indication or a new population — for FDA-approved drugs and to help accelerate
Drugs
FDA has approved an expanded dosing regimen for Lilly’s atopic dermatitis treatment Ebglyss (lebrikizumab-lbkz), allowing certain patients to receive maintenance injections once every eight weeks. Ebglyss was originally approved in the U.S. in 2024 as a first-line biologic treatment administered once every four weeks with or
FDA Policy/General
FDA has issued an untitled letter to contract manufacturer Formulated Solutions, citing GMP violations related to component testing and quality oversight at the company's Largo, FL, facility. In the 6/2 letter, FDA said its review of records submitted by the company in response to a September 2025
Drugs
Gilead and Merck say they are discontinuing the KEYNOTE-D46/EVOKE-03 study of Gilead’s Trodelvy (sacituzumab govitecan-hzly) and Merck’s Keytruda (pembrolizumab) as a treatment for certain patients with previously untreated metastatic non-small cell lung cancer whose tumors expressed PD-L1. A statement says the decision