Latest News
& Press Releases
Browse the latest news from BioSpace, and press releases from around the industry. Want to filter by date, keyword, and more? Search here.
TOP STORIES
Following a partial hold on another lead candidate last year, Sanofi is reinvigorating its MS pipeline with a Phase II win for its investigational anti-CD40L antibody frexalimab.
The regulator will provide PepGen with a letter within 30 days explaining why a clinical hold was placed on the company’s Phase 1 study of patients with myotonic dystrophy Type 1.
The company’s oral gut-targeting polymer, GLY-200, demonstrated promising safety and efficacy in patients with Type 2 diabetes, assessing the candidate as an adjunct treatment to diet and exercise.
Efforts are underway to fast-track approval for costly gene therapies and make them affordable to a wider patient group via reimbursement through Medicare and Medicaid.
Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.
Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.
Check out these hot Boston-based biotech companies hiring now.
Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.
Following a series of stumbles in Type 1 diabetes, Lexicon’s dual SGLT inhibitor sotagliflozin finally won the FDA’s approval in heart failure and will be marketed as Inpefa.
DUO-E trial data show AstraZeneca’s Imfinzi, either alone or in combination with Lynparza, boosts progression-free survival in endometrial cancer.
The Insight Partners published latest research study on “Diabetes Care Devices Market Forecast to 2028 - COVID-19
Eli Lilly’s recently registered Phase IIIb SURMOUNT-5 trial will compare its Mounjaro with Novo Nordisk’s Wegovy in obese or overweight patients with weight-related health conditions.
PRESS RELEASES
Source plant is widely regarded as one of the most valuable fragrance raw materials in the world Stage 2 contract follows successful Stage 1 completion in March 2026
Key Regulatory Benchmark Met, Differentiating DMX-101 from Traditional Opioid Analgesics Late-Breaking Results to be Presented at CPDD 2026 Annual Meeting
Live virtual fireside chat — investors, advisors, and life sciences analysts invited to attend Featuring Dermatologist Mary Spellman, M.D., with Phio CEO Robert Bitterman and Force Family Office CEO Steven Saltzstein
· First-in-class oral mechanism triggers natural satiety hormones, addressing key limitations of GLP-1 therapies · Phase I data demonstrate fat mass reduction, preservation of lean mass, 80% responder rate, and no serious adverse events
