WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for JAYPIRCA, a human drug product, for the purpose of patent extension. JAYPIRCA, developed by Loxo Oncology, Inc., is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, who have undergone at least two lines of systemic therapy, including a Bruton tyrosine kinase inhibitor. The product receive  more

WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for the human drug product LITFULO (ritlecitinib tosylate), a treatment for severe alopecia areata in adults and adolescents aged 12 and older. The decision was made following the submission of an application to the U.S. Patent and Trademark Office (USPTO) for a patent extension. This determination is in line with the requirements of the   more

WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for NGENLA (somatrogon-ghla), a human biologic product, which is eligible for patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984. The determination was made following applications for patent term restoration filed with the U.S. Patent and Trademark Office (USPTO) by OPKO Biologics Ltd. for U.S. P  more

WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has announced its determination regarding the regulatory review period for the human biological product ELREXFIO, which is developed by Pfizer Inc. The announcement comes after a request by the U.S. Patent and Trademark Office (USPTO) for FDA's assistance in determining the regulatory review period for patent term restoration related to this product. The review period is essential   more

WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has determined the regulatory review period for the human biologic product LAMZEDE (velmanase alfa-tycv), which is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in both adult and pediatric patients. This determination is a significant step for Chiesi Farmaceutici S.p.A., which has applied to the U.S. Patent and Trademark Office (USPT  more

WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration (FDA) has announced the determination of the regulatory review period for SKYCLARYS, a human drug product developed by Reata Pharmaceuticals, Inc. The product, which is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older, was approved for marketing on February 28, 2023. SKYCLARYS is designed to address the rare and progressive neurodegener  more

WASHINGTON, May 10 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration has issued a formal notice identifying the regulatory review period for the human drug product SUNLENCA, initiating a key step in the process that may lead to an extension of its patent. SUNLENCA, developed by pharmaceutical company Gilead Sciences, Inc., is an antiretroviral treatment used in the management of HIV-1 infection. The Food and Drug Administration made this determination fol  more

WASHINGTON, May 9 -- Rep. Maggie Goodlander, D-New Hampshire, issued the following news release: * * * Goodlander Statement on the Passing of Former United States Supreme Court Justice David Souter Concord, N.H. - Today, Congresswoman Maggie Goodlander released the following statement: "Justice David Souter was and always will be a true American hero. "He was a humble man with a granite backbone who always put our country and our Constitution first. His commitment to common sense was at t  more

CONCORD, New Hampshire, May 9 (TNSrep) -- The New Hampshire Department of Health and Human Services issued the following news release on May 8, 2025: * * * New Hampshire Medicaid Ranked First in the Nation for Mental Health Services Concord, NH - New Hampshire's Medicaid program ranks #1 in the nation for mental health services delivery according to a new report. Today, Governor Kelly Ayotte and Department of Health and Human Services (DHHS) Commissioner Lori Weaver celebrated another top ran  more

CONCORD, New Hampshire, May 9 -- The New Hampshire Department of Insurance issued the following news release on May 8, 2025: * * * New Hampshire Insurance Department Announces New Licensing Exam Vendor The New Hampshire Insurance Department (NHID) has selected PSI Services LLC (PSI) as the new vendor for administering insurance licensing examinations in the state. PSI will begin offering exams for producers, adjusters, and public adjusters starting July 1, 2025. Prometric, the Department's c  more

WASHINGTON, May 8 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release: * * * Pappas Continues to Stand Against Cuts to Medicaid and SNAP, Joins Effort to Block Republicans from Cutting Funding This week Congressman Chris Pappas (NH-01) signed a discharge petition (link is external) filed by Congressman Brendan F. Boyle (PA-02), that would force consideration of a special rule to prevent cuts to Medicaid and food assistance by amending the Congressional Budget Act to prote  more

WASHINGTON, May 9 -- Rep. Chris Pappas, D-New Hampshire, issued the following news release: * * * Pappas Statement on Passing of Justice Souter Today Congressman Chris Pappas (NH-01) issued the following statement after the passing of former U.S. Supreme Court Justice David Souter: "Justice Souter dedicated his life to the law and public service, and he always demonstrated a fidelity to the Constitution and embodied our New Hampshire values. This is a sad loss for our state and country, and  more

WASHINGTON, May 10 -- President Trump issued the following executive order on May 9, 2025: * * * KEEPING PROMISES TO VETERANS AND ESTABLISHING A NATIONAL CENTER FOR WARRIOR INDEPENDENCE By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered: Section 1. Purpose and Policy. Our Nation's security, prosperity, and freedom would not be possible without our veterans. Many service members paid the ultimate sacrifice. Many ot  more

WASHINGTON, May 9 -- Sen. Maggie Hassan, D-New Hampshire, issued the following news release: * * * Senator Hassan Statement on Passing of Former U.S. Supreme Court Justice David Souter WASHINGTON - Today, U.S. Senator Maggie Hassan released the following statement after the passing of former U.S. Supreme Court Justice David Souter: "Justice David Souter was an extraordinarily thoughtful jurist who exemplified our Granite State values every day. Dedicated to upholding the rule of law, Justic  more

WASHINGTON, May 10 -- The U.S. Department of Veterans Affairs issued the following statement on May 9, 2025: * * * VA statement regarding President Trump's executive order WASHINGTON - After President Trump signed an executive order to provide better care to Veterans, improve accountability for such care, and establish a National Center for Warrior Independence for homeless Veterans, Department of Veterans Affairs Secretary Doug Collins released the following statement: "Under President Trum  more

WASHINGTON, May 10 -- The White House issued the following fact sheet on May 9, 2025: * * * President Donald J. Trump Keeps Promises to Our Veterans and Establishes New Center for Homeless Veterans KEEPING OUR PROMISE TO OUR VETERANS: Today, President Donald J. Trump signed an Executive Order to provide better care to our veterans, improve accountability for such care, and establish a National Center for Warrior Independence for homeless veterans. * The Order directs the Secretary of Veteran  more