Bengaluru: The European Medicines Agency 's committee has recommended approval of French drugmaker Sanofi 's first-of-its-kind drug that delays onset of the insulin-dependent stage 3 of type 1 diabetes , it said on Friday. Teizeild, chemically known as teplizumab , was already approved in the U.S. in November 2022 for patients with stage 2 of the disease that typically show no symptoms. In March 2023, Sanofi had acquired U.S-based biotech Provention Bio for $2.9 billion, giving the French drugma

BOSTON, Nov. 14, 2025 /PRNewswire/ -- Intrinsic Therapeutics, Inc., the makers of the Barricaid® Bone-Anchored Annular Closure Device, announced today the first endoscopic Barricaid implantation in the Great Lakes Region was completed by Nick Nenadovich, MD, a University of Chicago trained, board-certified orthopedic surgeon. Continue Reading Intrinsic Therapeutics Announces the First Endoscopic Barricaid Implantation in the Great Lakes Region by Dr. Nick Nenadovich Dr. Nenadovich said, "Endosc

FLOWOOD, Miss., Nov. 14, 2025 /PRNewswire/ -- Zavation Medical Products, LLC ("Zavation"), a leading innovator in spinal device technology, proudly announces the launch of NanoPrime™, a next-generation implant material that combines the mechanical advantages of PEEK with the biological benefits of titanium through advanced titanium ion bond technology. Continue Reading Varisync NanoPrime ALIF Cage with Anchors Labyrinth Nanoprime Cervical Cage NanoPrime™ utilizes a cutting-edge nano-engineeri

London: Blood-thinning drugs that doctors often prescribe interchangeably after procedures to reopen narrowed heart arteries don't work equally well in patients with diabetes, a study from India found. All 1,800 study participants had Type 1 or Type 2 diabetes , and all had undergone minimally invasive interventions to clear a clogged coronary artery and prop it open using a drug-coated stent to help reduce the risk of reclogging. Afterward, they received aspirin plus either AstraZeneca's Brilin

Sunlight is vital for human health as it helps the body produce essential nutrients, such as vitamin D. However, too much sun exposure can significantly increase the risk of skin cancer. In a new study published in Nature Communications , researchers at the University of Chicago have discovered how prolonged exposure to ultraviolet (UV) radiation can trigger inflammation in skin cells through degradation of a key protein called YTHDF2. This protein acts as a gatekeeper in preventing normal skin

IDAHO FALLS, Idaho, Nov. 14, 2025 /PRNewswire/ -- International Isotopes Inc. (OTCQB: INIS) (the "Company" or "INIS") is pleased to announce its financial results for the third quarter and nine months ended September 30, 2025. Revenue from the sale of product for the third quarter of 2025 was $3,277,816, a decrease of $646,628 or 16%, compared to the same period in the prior year, and for the nine months ended September 30, 2025 was $10,172,036, an increase of $173,901 or 2% from the same period

The FDA on Friday revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys to add a boxed safety warning and restrict the therapy’s use to ambulatory patients, reflecting changes that the agency and company previously suggested. The FDA also said that it will require Sarepta to conduct an observational study “to further assess the risk of serious liver injury.” The postmarketing study will include around 200 patients — a considerable number — and will periodically assess

The FDA and generic drugmakers kicked off closed-door negotiations late last month over the fourth round of user fees, with the agency offering up its wish list of changes it wants to see from industry. Meeting at the FDA’s White Oak, MD campus on Oct. 22, the FDA told industry representatives that it wants to help address the occurrence of “data fidelity issues,” according to meeting minutes the agency posted on Thursday. Data integrity has been a major focus for the agency as it says it will l

Docket Number: FDA-2022-D-0108 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes how FDA (the Agency, or we) intends to evaluate a request for a waiver, with regard to a pH adjuster, under 21 CFR 314.99(b) (hereinafter waiver) of the requirement in 21 CFR 314.94(a)(9)(iii) and (iv) that a drug product intended for parenteral, ophthalmic, or otic use generally “must contain the same inactive ingredients and in the same concentration as the referenc

AUSTIN, Texas and TOKYO, Nov. 14, 2025 /PRNewswire/ -- According to DataM Intelligence, the Cardiovascular Biologics Market Size was valued at approximately USD 2.20 billion in 2024 and is projected to grow to USD 4.23 billion by 2033, representing a CAGR of 7.5% over the forecast period 2025-2033. This growth is driven by the increasing development of biologic and gene-based therapies targeting cardiovascular disease (CVD) pathways, including monoclonal antibodies (mAbs), siRNA-based therap