October 3, 2025
Clinical Updates
Caprelsa® (vandetanib) – Drug update (REMS removal)
September 25, 2025 - The FDA announced that they removed the Risk Evaluation and Mitigation Strategies (REMS) program for Sanofi Genzyme’s Caprelsa (vandetanib).
Clinical Updates
Evkeeza® (evinacumab-dgnb) – Expanded indication
September 26, 2025 - Regeneron announced the FDA approval of Evkeeza (evinacumab-dgnb), as an adjunct to diet and exercise and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies to reduce LDL-C in adults and pediatric patients, aged 1 year and older, with homozygous familial hypercholesterolemia (HoFH).
Clinical Updates
Tremfya® (guselkumab) – Expanded indications
September 29, 2025 - J&J announced the FDA approval of Tremfya (guselkumab), for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy or active psoriatic arthritis.
Drug Approvals
Bondlido® (lidocaine) – New drug approval
September 24, 2025 - The FDA approved MEDRx USA’s Bondlido (lidocaine) 10% topical system, in adults for relief of pain associated with postherpetic neuralgia (PHN).
Drug Approvals
Clotic (clotrimazole) – New drug approval
September 26, 2025 - The FDA approved Carwin Pharmaceutical’s Clotic (clotrimazole) otic solution, for the treatment of fungal otitis externa (otomycosis) due to Aspergillus species and Candida species in patients 18 years of age and older.
Drug Approvals
Enoby™ (denosumab-qbde) – New biosimilar approval
September 29, 2025 - Hikma and Richter announced the FDA approval of Enoby (denosumab-qbde), biosimilar to Amgen’s Prolia® (denosumab).
Drug Approvals
Inluriyo (imlunestrant) – New drug approval
September 25, 2025 - Eli Lilly announced the FDA approval of Inluriyo (imlunestrant), for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Drug Approvals
Palsonify™ (paltusotine) – New orphan drug approval
September 25, 2025 - Crinetics Pharmaceuticals announced the FDA approval of Palsonify (paltusotine), for the treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.
Drug Approvals
Xtrenbo™ (denosumab-qbde) – New biosimilar approval
September 29, 2025 - Hikma and Richter announced the FDA approval of Xtrenbo (denosumab-qbde), biosimilar to Amgen’s Xgeva® (denosumab).
New Generics
Endometrin® (progesterone) – First-time generic
September 29, 2025 - Xiromed launched an AB-rated generic version of Ferring’s Endometrin (progesterone) vaginal insert.