Drugs
Elevar Therapeutics has submitted an NDA for lirafugratinib as a second-line treatment for patients with cholangiocarcinoma whose tumors harbor FGFR2 fusions or rearrangements. Cholangiocarcinoma (bile duct cancer) is a rare malignancy, whose treatment options are limited, particularly after first-line therapy. The NDA is supported by clinical data from
Drugs
Sen. Rick Scott (R-FL) has introduced legislation that would require prescription drug labels in the U.S. to disclose where drugs and their active pharmaceutical ingredients are manufactured, aiming to increase transparency in a supply chain that relies heavily on overseas production. The bill, the Consumer Labeling for Enhanced
Devices
On 2/2, FDA is discontinuing the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850). FDA will also no longer use Inspection of Medical Device
Devices
Grail has submitted the final module of its PMA for the company’s multi-cancer early detection blood test. The Galleri test, which was designated a Breakthrough Device by FDA in 2018, is designed to detect cancer signals and predict their tissue of origin from a single blood draw. It
Drugs
FDA has granted Biogen a breakthrough therapy designation for its experimental antibody litifilimab for treating cutaneous lupus erythematosus (CLE), a chronic autoimmune skin disease for which there are no approved targeted therapies. The designation was based on the totality of data generated to date for litifilimab, including results from the
Drugs
A group of Democratic senators is pressing HHS’ Office of Inspector General to clarify how it will oversee direct-to-consumer prescription drug sales tied to the forthcoming TrumpRx Web site, raising concerns about potential violations of federal fraud and abuse laws. In a 1/29 letter to HHS, Sens.
FDA Policy/General
The current climate at FDA is unprecedented in terms of the depth and breadth of its politicization. That’s the view of University of Southern California economist and associate professor of public policy Genevieve Kanter in an online interview with PharmaVoice. She says that while all presidential administrations use appointed
Drugs
FDA has approved Tenpoint Therapeutics’ Yuvezzi (carbachol and brimonidine tartrate ophthalmic solution) 2.75%/0.1% (previously known as Brimochol PF) as the only dual-agent eye drop to treat presbyopia in adults. A company statement says the approval was based on positive data from two Phase 3 studies enrolling
Devices
FDA has issued an updated guidance clarifying when clinical decision support (CDS) software functions fall outside the definition of a regulated medical device, offering developers greater insight into how the agency interprets its statutory authority over digital health tools. The document, Clinical Decision Support Software, which supersedes an identically titled
Drugs
Reduced FDA staffing levels and high turnover are extending regulatory timelines and forcing drug developers to invest more heavily in upfront planning, according to an industry consultant. In a recent interview with Applied Clinical Trials, Charlie Paterson, a partner at PA Consulting, said sponsors are facing longer wait times for
Biologics
Robert Malone, the vice chair of the CDC Advisory Committee on Immunization Practices (ACIP) and a close ally of HHS secretary Robert F. Kennedy Jr., has publicly accused FDA commissioner Marty Makary of blocking the effort to remove mRNA Covid vaccines from the market. Axios reports that when Malone responded
Devices
As part of its MDUFA 5 commitment to promote international harmonization and provide additional CDRH resources for that work, the Center conducts annual assessments of its international activities. The 2025 report lists the five strategies envisioned in the CDRH strategic plan on international harmonization: * increase engagements in international harmonization, convergence,
Drugs
A Congressional Research Service (CRS) background paper on “‛Skinny Labels’ for Generic Drugs Under Hatch-Waxman” raises changes that Congress could consider if it wanted to clarify the provisions. The paper gives extensive background on the generic drug approval process under Hatch-Waxman and the role of so-called skinny
Biologics
FDA has accepted for review a Summit Therapeutics BLA seeking approval for ivonescimab in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) post-tyrosine kinase inhibitor (TKI) therapy. The agency has set a user
Drugs
To meet the legal requirement that it take final action on a petition within 150 days, FDA has denied without commenting on the specifics an 8/29/2025 petition submitted by Foley & Lardner asking for restrictions on approval for any ANDA citing Novo Nordisk’s Ozempic (semaglutide) as the
Devices
The CDRH 2025 Annual Report says the Center authorized 124 novel medical devices last year, including the first blood test to diagnose Alzheimer’s disease. The report says the number of authorizations was one of the highest in the Center’s more than 40-year history. Other accomplishments cited by
Biologics
FDA has placed clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the identification of a central nervous system tumor in a single patient treated with one of its candidates. A hold was placed on RGX-111, an experimental gene therapy for mucopolysaccharidosis Type
Drugs
Boehringer Ingelheim says its investigational kidney drug apecotrep reduced proteinuria by 40% compared with placebo in a Phase 2 clinical trial involving patients with primary focal segmental glomerulosclerosis (FSGS), a rare and progressive kidney disease with no approved targeted treatments. The 12-week, placebo-controlled study showed the strongest effect
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a TV ad for ARS Pharmaceutical’s Neffy (epinephrine nasal spray) is false and misleading. A 1/23 Untitled Letter says the agency is concerned that it raised similar issues in a 9/9/2025 Untitled Letter and asked the company
Drugs
Public Citizen has filed a suit to force the Trump administration to release the texts of the drug pricing agreements it has reached with Pfizer and Eli Lilly. The advocacy group says it was forced to file suit in the DC federal court because both HHS and the Department of
Devices
FDA’s recent issuance of Warning Letters to four direct-to-consumer testing companies over the use of unauthorized at-home blood collection devices underscores that self-collection kits remain subject to FDA oversight despite a recent court ruling that curtailed the agency’s authority over laboratory-developed tests (LDTs)
Drugs
FDA has cited Nubratori Inc., a California-based sterile drug outsourcing facility, for multiple manufacturing and contamination-control deficiencies following a December inspection of the company’s Torrance site, according to an agency inspection report. The Form FDA 483 said the company failed to establish adequate written procedures for cleaning