Jan 2, 2025 · In some good news for the US vaccines developer, whose stock has fallen 66% in the past 12 months, Moderna on Friday announced ongoing support from the US Department of Health and Human Services (HHS) to accelerate the development of mRNA-based pandemic influenza vaccines.

The two day event offers a variety of means for networking and collaboration: Hackathons offering a hyper-interactive session where attendees work as a team to hack strategic issues.

May 15, 2005 · The US Food and Drug Administration is warning the public about the sale of counterfeit versions of Pfizer's Lipitor (atorvastatin) and Viagra (sildenafil), and an unapproved product promoted as a "generic" version of Eli Lilly's Evista (raloxifene) to US consumers at pharmacies in Mexican border towns.

Dec 28, 2024 · The US Food and Drug Administration (FDA) on Friday approved nivolumab and hyaluronidase-nvhy, under the trade name Opdivo Qvantig, from US pharma major Bristol Myers Squibb (NYSE: BMY), for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in ...

Dec 17, 2024 · sandoz news page. Swiss generic and biosimilar medicines major Sandoz today announced a number of steps to resolve the US Generic Drug Antitrust Class Action Litigation.

Nov 28, 2024 · The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). The FDA determined the priority initiatives in collaboration with industry and the public, including feedback received during the FY 2024 Generic Drug Science and Research Initiatives Public Workshop.. The FY 2025 GDUFA science and research priorities encompass ...

Nov 7, 2024 · The company was launched by Aditum Bio in November 2024. Oblenio Bio was formed in conjunction with an exclusive option and license agreement with launched by Aditum Bio to develop LBL-051, a novel tri-specific T-cell engager developed using …

Dec 24, 2024 · Viatris faces US FDA regulatory action on its Indore, India facility, with a warning letter and import alert restricting 11 products while exempting four for shortages. The company is implementing corrective measures and engaging with the FDA to address compliance issues.

Dec 27, 2024 · The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene.

Dec 19, 2024 · US biopharma Vertex Pharmaceuticals today announced results from its Phase II study of suzetrigine, an investigational, oral, highly selective NaV1.8 pain signal inhibitor in people with painful lumbosacral radiculopathy (LSR), also known as sciatica.