Drugs
Gilead Sciences is petitioning FDA to rescind its decision to file a Cipla 505(b)(2) application for an apparent duplicate of Gilead’s Descovy (emtricitabine and tenofovir alafenamide) tablets. The petition also asks the agency to refuse to grant the Cipla product an A rating, reflecting a determination of
Drugs
FDA has issued a Warning Letter to New Life Pharma citing serious manufacturing and regulatory violations tied to the company’s production of injectable weight-loss and diabetes drugs, including semaglutide- and tirzepatide-based products. Compounding the violations, FDA says the company refused to grant investigators access to certain areas
Drugs
FDA has extended by three months its review of a Sanofi BLA for a subcutaneous formulation of Sarclisa (isatuximab-irfc) for use in combination with standard-of-care regimens for patients with multiple myeloma across all indications currently approved for the drug’s intravenous (IV) formulation. The revised target action
Drugs
FDA has released the form FDA-483 with two observations from the agency’s 3/9-3/11 inspection at Vet4U, a Clay, NY, drug distributor. The specific inspection observations were: * failure to have adequate systems and processes to enable compliance with the verification requirements of section 582(c) of
Drugs
A 4/20 petition submitted by Covington & Burling to FDA on behalf of an unidentified major pharmaceutical company urges the agency to immediately establish a formal process for redacting confidential commercial information and trade secrets before releasing Complete Response Letters (CRLs) for unapproved drug and biologic applications. Historically, the
Drugs
Nineteen Senate Democrats, led by Ron Wyden (D-OR), have introduced legislation aimed at forcing the Trump administration to disclose the terms of agreements it has struck with major pharmaceutical companies, arguing the deals primarily benefit industry rather than patients. The proposal, dubbed the Drug Deal Disclosure Act, would require
Drugs
FDA has approved an expanded indication for Sanofi’s Tzield (teplizumab), allowing its use in children as young as one year old to delay the onset of stage 3 Type 1 diabetes. The decision broadens Tzield’s previous U.S. approval, which covered patients aged eight and older with stage
Drugs
An 8/12-8/16/2025 FDA inspection at the Xiamen Kang Zhongyuan Biotechnology Co. drug manufacturing facility in Fujian Sheng, China, found its products are adulterated due to being prepared, packed, or held under insanitary conditions. A just-released 3/23 Warning Letter says the company did not have
Drugs
Two University of Pittsburgh pharmacy professors say FDA’s new Adverse Event Monitoring System (AEMS) dashboard was launched with a consequential omission. Writing in a column in The Scientist, the professors say FDA “launched a powerful public-facing tool without building in the infrastructure to help people understand what the
Drugs
FDA commissioner Marty Makary says the agency will deploy its new “national priority voucher” program to significantly shorten drug review timelines for three psychedelic therapies at the center of president Donald Trump’s executive order signed over the weekend (see earlier story). The vouchers could reduce review periods to roughly
Drugs
A 7/21-7/24/2026 FDA inspection at the University of California at San Francisco (UCSF) radiopharmaceutical drug manufacturing facility in San Francisco, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/13 Warning Letter says the specific violations were: * failure to
Drugs
A 10/6-10/20/2025 FDA inspection at the Par Health USA/Endo USA drug manufacturing facility in Rochester, MI, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/15 Warning Letter says the specific violations were: * failure to perform operations within specifically
Drugs
President Trump has signed a sweeping executive order aimed at accelerating the development and availability of psychedelic-based treatments for patients with serious mental illness, directing federal agencies to streamline regulatory pathways, expand research funding, and improve patient access to investigational therapies. The order places significant new responsibilities on FDA
Drugs
FDA has issued updated guidance clarifying how patients, physicians, and drug developers can access investigational therapies outside of clinical trials, incorporating policy changes enacted under recent federal laws. The document, Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers, reflects the agency’s latest thinking on so-called
Drugs
Nektar Therapeutics is reporting new 52-week data from its mid-stage REZOLVE-AA trial, showing continued improvement in hair regrowth among patients with severe-to-very-severe Alopecia areata treated with its investigational therapy rezpegaldesleukin. The results come from a 16-week blinded extension of the Phase 2b study,
Drugs
FDA has told Passage Bio that a randomized controlled trial will be required to support approval of its experimental gene therapy for a rare form of dementia, raising the regulatory bar as the company evaluates the future of the program. The feedback, delivered during a recent Type C meeting, means
Drugs
FDA has released a draft guidance outlining how drugmakers should establish impurity specifications for antibiotics produced by fermentation and semi-synthetic processes, aiming to standardize quality expectations for a complex class of medicines. The CDER document provides recommendations for identifying, testing and setting acceptance criteria for impurities and degradation products
Drugs
FDA has granted Opna Bio a fast track designation for its investigational therapy OPN-6602 and its use in treating patients with relapsed or refractory multiple myeloma who have undergone at least four prior lines of therapy. The oral small-molecule inhibitor targeting EP300 and CREB-binding protein is currently
Drugs
Since 2021, the FDA Satellite Laboratory Branch of the National Forensic Chemistry Center in the Office of the Chief Scientist has analyzed and helped to block two million lot units (capsules and tablets) of illegal, counterfeit, and other unsafe drug and medical products from reaching U.S. consumers and patients.
Drugs
FDA is signaling a potential expansion of testosterone replacement therapy (TRT) use, encouraging drugmakers to explore whether existing products could be approved to treat low libido in men with idiopathic hypogonadism, according to a new agency notice. The move marks an early regulatory step that could broaden the scope of
Drugs
The Institute for Clinical and Economic Review (ICER) has released a white paper with recommendations for improving the FDA accelerated approval pathway. The paper, “Strengthening FDA’s Accelerated Approval Pathway: Progress and Unfinished Business,” reviews recent regulatory and market changes and identifies several policies that could be adopted to improve
Drugs
The Contraceptive Study Group says additional Warnings and Safety Information should be added to the labeling for hormonally active contraceptives. In a petition, the group says the contraceptives have been on the market for 50 years, and in that time, numerous studies have documented side effects that can have a