Why Aviva Bio’s deuterated testosterone may change hormone therapy for women
Aviva Bio’s AVA‑291 receives FDA development feedback for women’s testosterone therapy. See what makes it safer and what happens next in clinical trials.
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 […]
Organon’s NEXPLANON earns five-year approval: How this changes the LARC landscape
FDA approves NEXPLANON for five years of use with REMS program. Find out how this reshapes contraceptive access, safety, and policy impact.
Can ABCL635 redefine non-hormonal menopause treatment? Inside AbCellera’s Phase 2 push
AbCellera advances ABCL635 into Phase 2 for hot flashes. Find out what this means for non-hormonal menopause care and the biotech’s GPCR strategy.
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 […]