An FDA decision on KalVista Pharmaceuticals' experimental drug sebetralstat — which could become the first oral, on-demand treatment for hereditary angioedema (HAE) — is being pushed back. The agency had aimed to issue a verdict by June 17, but now says it needs about four more weeks due to "heavy workload and limited resources," according to the company. No additional data requests or safety concerns have been raised.The delay comes amid broader turmoil at the FDA, following mass layoffs earlie

With Carvykti (ciltacabtagene autoleucel) producing "science fiction-like" efficacy, Johnson & Johnson is pulling back the curtain on another CAR-T therapy — one that targets two antigens simultaneously. The company on Friday provided a first look at clinical data for JNJ-4496, an investigational dual-targeting therapy that binds CD19 and CD20 antigens on malignant B-cells.JNJ-4496, formerly known as C-CAR039, incorporates a 4-1BB costimulatory domain intended to enhance binding strength and per

UCB announced a "major" investment to expand its biologics manufacturing capacity in the US. The company noted that the location of the new facility, which will employ around 300 staff, has yet to be decided."This investment reflects our growing impact in the US and our ambition to bring our forthcoming pipeline to patients around the world," remarked CEO Jean-Christophe Tellier. The company noted that since 2017, its workforce in the US has expanded by 73% to around 2000 employees, backed by $4

Moderna gained expanded FDA approval of its respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345), allowing use of the mRNA-based shot in individuals 18-59 years of age who are at increased risk of disease. The jab was first cleared just over a year ago for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.Despite being only the third RSV vaccine approved in the US — behind GSK's Arexvy and Pfizer's Abrysvo — mRESVIA has so underperf

BEIJING--(BUSINESS WIRE)--Latest data of InnoCare’s (HKEX: 09969; SSE: 688428) robust oncology pipelines were presented at the ongoing European Hematology Association (EHA) 2025 Congress. First presentation of the efficacy and safety data for first-line treatment of CLL/SLL with BCL2 inhibitor Mesutoclax in combination with BTK inhibitor orelabrutinib Poster Presentation: 1. First Presentation of Efficacy and Safety Data for First-Line Treatment of CLL/SLL with BCL2 Inhibitor Mesutoclax in Combi

TAINAN, June 12, 2025 /PRNewswire/ -- Merry Life Biomedical Company announces the launch of its global Phase II clinical trial for TML-6, a novel oral small molecule drug targeting early-stage Alzheimer's disease (AD). TML-6 combines multiple mechanisms, including anti-oxidative effects (Nrf2 activation), melioration of autophagy function (autolysosomal activation), anti-amyloid accumulation (β-amyloid clearance), and anti-inflammatory effects (through NF-κB inhibition) through autolysosome pa

Bengaluru: Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after the Food and Drug Administration placed a clinical hold, the drug developer said on Thursday. Shares of the company fell nearly 10% after the bell. The company was testing a drug named LTI-03 to treat patients with idiopathic pulmonary fibrosis (IPF). The disease causes scarring of the lungs that makes it harder for them to work properly. Rein said in a filing tha

Bengaluru: The U.S. Food and Drug Administration on Thursday expanded the use of Moderna's respiratory syncytial virus vaccine to a lower group of adults aged 18 to 59 years at increased risk for disease. Moderna's RSV shot, mRESVIA, was the first non-COVID-19 messenger RNA-based (mRNA) vaccine to be approved in the United States. The shot, the company's second product, is already approved for the prevention of RSV-associated lower respiratory tract disease in adults aged 60 or older. While the

Bengaluru: The U.S. Food and Drug Administration on Thursday approved UroGen Pharma 's drug to treat a type of bladder cancer, providing an alternative treatment as opposed to traditional surgical procedures. U.S.-listed shares of the Israel-based company were up about 50% in afternoon trading. The approval follows a late-stage trial with 223 patients, in which 78% of the participants showed a complete response, meaning all signs of cancer disappeared in response to the treatment. The drug, bran

iStock, Robert Way Friday’s deal with fits neatly within AstraZeneca’s business development strategy of upping investments in AI and in China. AstraZeneca put down $110 million upfront to partner with China’s CSPC Pharmaceutical, aiming to leverage AI to develop novel oral therapies for a wide variety of chronic diseases, in a deal announced Friday. Aside from its initial commitment, AstraZeneca also pledged up to $1.62 billion in development milestones, as well as sales-based contingent payme