Pharmas Hope FDA PreCheck Can Help Avoid Facility-Related Drug Rejections Executives from Eli Lilly, Merck and other companies foresee the FDA’s new onshoring proposal being anything from a bureaucratic waste of time to a transformative program that will eliminate inspection-related…
Study shows Roche Gazyva/Gazyvaro significantly improves outcomes in pediatric and young adult patients with idiopathic nephrotic syndrome. Roche Announces Positive Phase III Results for Gazyva in Idiopathic Nephrotic Syndromeannounced today statistically significant and clinically meaningful results from the phase III…
Gsk Partnership to advance first-in-class siRNA therapy for COPD and other respiratory diseases. GSK plc and Empirico Inc. (Empirico), a clinical-stage biotechnology company with leading capabilities in human genetics-driven target discovery and siRNA medicines, today announced that they have entered…
Health Canada Grants Authorization for LEQEMBI®” (lecanemab) for the Treatment of Early Alzheimer’s Disease In Canada, lecanemab is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer’s disease…
4 Huntington’s Therapies Chasing UniQure Last month, “historic positive results” from uniQure’s gene therapy snapped the Huntington’s community out of years of failure. As the biotech prepares to submit for FDA approval, BioSpace looks at four more candidates on the near horizon.…
Regeneron Cans 2seventy-Acquired CAR T Candidate for Lymphoma in ‘Strategic’ Move The discontinued CAR T therapy bbT369 came to Regeneron when the pharma bought all of 2seventy bio’s pipeline assets for $5 million upfront in January 2024.”Regeneron is pulling the…
CHMP Recommends Scemblix for Newly Diagnosed CML in Europe, Offering Superior Efficacy and Tolerability Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the…
CHMP Recommends Saphnelo Subcutaneous Administration for SLE in the EU, Offering Convenient Self-Administration Option AstraZeneca has announced that its fully human monoclonal antibody Saphnelo (anifrolumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP)…
Tezspire Secures U.S. FDA Approval for Chronic Rhinosinusitis with Nasal Polyps, Expanding Its Reach Beyond Severe Asthma AstraZeneca and Amgen have announced that their jointly developed biologic, Tezspire (tezepelumab), has received U.S. Food and Drug Administration (FDA) approval for the…
Grifols Strengthens U.S. Diagnostic Manufacturing with New San Diego Facility Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), a leading global healthcare company specializing in plasma-derived medicines and innovative diagnostic solutions, has officially commenced production at its newly inaugurated facility in…
FDA’s Orphan Drug Leadership Shifts Amid Policy Changes and Department-Wide Shakeups Sandra Retzky, formerly the top orphan drug regulator at the FDA, is no longer serving as director of the Office of Orphan Products Development. The departure, first reported by…
AbbVie Announces FDA Approval of Updated RINVOQ® (upadacitinib) Indication for Inflammatory Bowel Disease NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ – AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug…