Two new therapies are now FDA approved to treat the sexually transmitted infection gonorrhea, with Innoviva Inc.’s Nuzolvence (zoliflodacin) and GSK plc’s Blujepa (gepotidacin) offering additional antibiotic options comparable to standard of care. Both products had fast track, qualified infectious disease product and priority review designations.

The quest for metabolic disease assets continues with another player promising top dollar for novel therapeutics that deliver. Copenhagen, Denmark-based Zealand Pharma A/S entered a collaboration and license agreement with newly formed OTR Therapeutics to pursue next-generation small-molecule therapeutics, beyond the Danish firm’s current peptide pipeline candidates focused on the GLP-1, GLP-2, GIP, amylin and glucagon mechanisms.

Eli Lilly and Co.’s latest phase III results for the obesity and overweight populations suggest its triple agonist, retatrutide, can deliver significant weight loss that, in turn, leads to reduced osteoarthritis knee pain.

Novartis AG’s monoclonal antibody, ianalumab (VAY-736), when added to standard-of-care eltrombopag, extended disease control of primary immune thrombocytopenia (ITP) by 45%, according to data presented Dec. 9 during a late-breaker abstract session at the 67th American Society of Hematology’s annual meeting in Orlando, Fla.

Impressive results of a potential second-line combination treatment for multiple myeloma from the Majestec-3 trial of teclistamab plus daratumumab raised eyebrows at the American Society of Hematology’s 67th annual meeting, with the combination showing an 83.4% rate of progression-free survival at three years vs. 29.7% for standard of care.

Targeted therapies and immunotherapies continue to show better results than chemotherapy in investigator-initiated and company-sponsored cancer trials, and newer options demonstrate improvements over older ones, supporting potential shifts in how patients are treated.

While several targeted therapies are approved for acute myeloid leukemia, a 2023 U.K. study found that median survival following diagnosis was only about seven months, highlighting the need not only for new therapies, but for a faster regulatory strategy. At the American Society of Hematology’s 67th annual meeting in Orlando Dec. 6, researcher Jesse Tettero presented data supporting the use of a measurable residual disease (MRD) surrogate endpoint in acute myeloid leukemia (AML) research.

After a more than 13-year period of stability with Janet Woodcock as the head of CDER, with Patrizia Cavazzoni taking charge during the next four years of former U.S. President Joe Biden’s tenure, the FDA division has had no fewer than five different people in charge throughout 2025. Up to bat now as acting director is Tracy Beth Høeg, a physician and epidemiologist who co-authored a paper in 2022 with CBER Director Vinay Prasad, FDA Commissioner Marty Makary and others demonstrating that COVID-19 boosters and college vaccine mandates were harmful to young men due to myocarditis risks.

Shares of Cosmo Pharmaceuticals NV rose sharply on Dec. 3 following top-line pivotal phase III data showing a statistically significant and clinically meaningful improvement in male androgenetic alopecia patients receiving clascoterone 5%, the first topical androgen receptor inhibitor, which uses the same active ingredient as the company’s acne treatment, Winlevi.