Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad produced by Bristol Myers Squibb’s Karuna Therapeutics unit for its Cobenfy (xanomeline and trospium chloride) capsules, for oral use, is false or misleading. A 12/15 Notice of Violation describes the ad and says its claims and
Drugs
FDA has released the form FDA-483 issued following a 10/6-10/14 inspection at the UBI Pharma drug manufacturing facility in Hsinchu, Taiwan. The five inspection observations were: * equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations
Drugs
An Eli Lilly investigational oral obesity drug helped patients largely maintain weight loss after transitioning off injectable incretin therapies, marking what the company describes as the first Phase 3 evidence supporting a switch from weekly injections to a daily pill. Lilly says that its once-daily oral GLP-1 receptor
Drugs
Novo Nordisk has submitted an NDA to FDA for once-weekly CagriSema (cagrilintide 2.4 mg and semaglutide 2.4 mg) injection to be used with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long-term in adults with obesity or
Devices
FDA says it has begun enforcement actions against companies illegally marketing breast binders to children, placing the agency’s role at the center of a broader federal crackdown announced by HHS on what it calls sex-rejecting medical procedures for minors. The agency says it is issuing Warning Letters to
Drugs
FDA officials and pharmaceutical industry representatives are at odds over how far to go in formalizing review timelines and expanding transparency as negotiations continue over the next reauthorization of the Prescription Drug User Fee Act, according to just-released minutes from an 11/18 meeting. During a two-hour virtual
Drugs
FDA has approved a new subcutaneous formulation of Johnson & Johnson’s lung cancer drug amivantamab, allowing the therapy to be administered in minutes rather than hours and expanding options for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval of Rybrevant Faspro, a co-formulation of
Drugs
A pivotal lung cancer trial of ifinatamab deruxtecan has been placed on a global clinical hold after reports of treatment-related deaths from lung toxicity, dealing a fresh setback to antibody-drug conjugates that use Daiichi Sankyo’s deruxtecan payload, according to a report on ApexOnco (oncologypipeline.com). The Phase
Drugs
In letters to AstraZeneca, Lilly, Novo Nordisk, and Pfizer, congressional Democratic health leaders are asking for detailed information on the companies’ agreements with the Trump administration to lower prices for some of their drugs in some markets. In a statement (includes links to the letters to the companies) from Democrats
Drugs
FDA has issued a Warning Letter to Catalent’s Bloomington, IN, drug manufacturing plant, citing significant violations of current good manufacturing practice (CGMP) regulations after investigators found repeated failures to properly investigate contamination events and aseptic processing risks. The facility, which was acquired by Novo Nordisk in 12/2024, has
Drugs
Diamond Research Foundation founder Beth Rosenshein is petitioning FDA to update the Indications and Usage section of the labeling for Pfizer’s Premarin (conjugated estrogens tablets) “to include pertinent information about the estrogen hormone equilin.” The petition says equilin is a major component of Premarin, comprising 22%-30% of its
FDA Policy/General
Two Mintz attorneys say a recent FDA announcement that it has deployed agentic artificial intelligence (AI) raises concerns for regulated industries. Writing in their firm’s online newsletter, Joanne Hawana and Benjamin Zegarelli say agency officials predict that integrating agentic AI into regulatory workflows will lead to greater efficiency and
Drugs
GSK has won FDA approval for Exdensur (depemokimab-ulaa), the first ultra-long-acting biologic for severe asthma in the U.S., with dosing just twice a year. The product was approved as an add-on maintenance treatment for adults and adolescents aged 12 and older with severe asthma driven
Drugs
FDA has denied a 2/19/2019 petition for reconsideration submitted by Akebia Therapeutics asking the agency to reconsider its decision denying five-year new chemical entity exclusivity to the company’s Auryxia (ferric citrate) oral tablets. In its denial letter, FDA says it denied the company’s original request
Drugs
FDA's recent plans to further reduce clinical trial requirements for drugs are raising concerns in some outside experts, according to an online Medshadow column. The column says the agency action, which was confirmed by commissioner Marty Makary in a Stat interview, could allow drug companies to pursue agency
FDA Policy/General
House Republicans on the Energy and Commerce Committee on Wednesday blocked an effort by Democrats to compel HHS secretary Robert F. Kennedy Jr. to testify before Congress, as partisan tensions escalated over vaccine policy and the federal response to disease outbreaks. The failed subpoena vote came during a hearing of
Biologics
Sen. Ron Johnson (R-WI) is demanding that FDA turn over records related to an internal review that linked Covid-19 vaccinations to the deaths of at least 10 children, escalating a long-running Republican investigation into vaccine safety and federal oversight during the Biden administration. In a 12/15
Devices
FDA has published a guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, clarifying how the agency evaluates real-world data to determine whether they are sufficient for generating the types of real-world evidence that can be used in FDA regulatory decision-making for
Drugs
FDA has chosen two investigational drugs from Merck for expedited regulatory reviews under its Commissioner's National Priority Voucher program, according to internal agency documents reviewed by Reuters. The drugs — a cholesterol treatment and an oncology therapy — could become the 17th and 18th products included in the fast-track
Drugs
A 6/9-6/13 FDA inspection at the 3D Imaging Drug Design and Development drug manufacturing facility in Little Rock, AR, found multiple violations in its production of positron emission tomography (PET) drugs. A 12/4 Warning Letter says specific current good manufacturing practice (CGMP) violations were: * company facilities
Drugs
FDA has extended the review of Aldeyra Therapeutics’ NDA resubmission for reproxalap, pushing back a regulatory decision on the investigational dry eye disease treatment by three months. Aldeyra says the agency has set a new user fee review action target date of 3/16/2026 after classifying the company’s
Drugs
FDA has published a draft guidance, Study of Sex Differences in the Clinical Evaluation of Medical Products, with recommendations for (1) increasing the enrollment of females in clinical trials and non-interventional studies; (2) analyzing and interpreting sex-specific data; and (3) including sex-specific information in regulatory submissions of