FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo
Under the 2023 collaboration agreement, Assembly Bio will receive $35 million for Gilead’s exercise of the HSV program option
The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers
This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care
Full approval will depend on verification of clinical benefit in a confirmatory trial
The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity
Production at Biocon Biologics’ own facilities is scheduled to begin once technology transfers and regulatory approvals are finalized
The platform aims to serve doctors, consumers, and healthcare facilities by providing AI-assisted clinical decision tools, personalized health insights, and improved diagnostic capabilities
NUFYMCO BLA has been approved by the USFDA
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