Organon’s NEXPLANON gains FDA nod for five-year use, but REMS adds new provider hurdles

Organon’s NEXPLANON gains FDA nod for five-year use, but REMS adds new provider hurdles

Organon’s etonogestrel implant NEXPLANON has received FDA approval for extended use up to five years, marking a significant regulatory win for the women’s health–focused pharmaceutical company. The decision, which comes via a supplemental new drug application (sNDA), builds on existing data supporting the implant’s high efficacy and safety profile and broadens its potential utility among […]

What the Cosette–Mayne Pharma breakdown signals for future pharma M&A in Australia

What the Cosette–Mayne Pharma breakdown signals for future pharma M&A in Australia

Cosette Pharmaceuticals, Inc. has officially terminated its proposed AUD 7.40-per-share acquisition of Mayne Pharma Group Limited after the Australian government blocked the transaction. The decision was confirmed on December 9, 2025, and followed by Mayne Pharma’s own termination notice issued on December 11. The companies cited both the Treasurer of Australia’s ruling and the expiry […]