The U.S. FDA has approved the priority sNDA for a new first-line maintenance therapy in extensive-stage small-cell lung cancer from Jazz Pharmaceuticals plc. Zepzelca (lurbinectedin) can now be combined with Tecentriq (atezolizumab, Roche AG) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza, Roche) as a maintenance therapy for adults who haven’t progressed after first-line induction therapy with atezolizumab, carboplatin and etoposide. Read More
With U.S. President Donald Trump’s administration vocally opposed to abortion, the U.S. FDA has approved a new generic version of the pill that makes the procedure possible medically: mifepristone, once better known as RU-486. Read More
Nanyang Biologics Pte. Ltd. has entered a $1.5 billion business combination agreement with RF Acquisition Corp II, a Nasdaq-listed special purpose acquisition company. Singapore-based Nanyang Biologics (NYB) is building a hybrid platform to revolutionize drug discovery by combining machine learning with natural compound libraries, and NYB claims it is developing one of the world’s largest AI-curated collections of bioactive compounds. Read More
Biopharma financings from January through September 2025 totaled $47.1 billion, a sharp decline from 2024’s $86.7 billion during the same period and well below the highs of 2020 and 2021. The slowdown was driven largely by weaker follow-on activity, which brought in $12.9 billion compared to more than $40 billion last year. Read More
Although type 2 diabetes tends to get more airtime, type 1 diabetes also had drawn a number of the developers to the table. Recently winning the attention of Wall Street is SAB Biotherapeutics Inc., which offered data during the European Association for the Study of Diabetes annual meeting. Vertex Pharmaceuticals Inc. and Biomea Fusion Inc. are among the other players. Read More
Mari Serebrov, BioWorld’s regulatory editor, shares how the publication’s 35-year commitment to fact-based, expert-driven journalism helps readers navigate complexity and make informed decisions. Read More
Regulatory snapshots, including global drug submissions and approvals, and other regulatory decisions and designations: Aavantgarde, Aminex, BMS, Calico, Nacuity, Prothena, Taysha Gene Therapies. Read More
