Second Oral Gonorrhea Option, Nuzolvence, Approved
On Dec. 12, 2025, the US Food and Drug Administration (FDA) approved Innoviva Specialty Therapeutics’ Nuzolvence® (zoliflodacin) oral suspension, a first-in-class, single-dose treatment for uncomplicated urogenital gonorrhea in patients aged 12 years and older weighing at least 77 pounds. This approval introduces a novel spiropyrimidinetrione antibiotic that inhibits bacterial type II topoisomerase, offering an alternative to injectable ceftriaxone and oral Blujepa® (gepotidacin – GSK), approved on Dec. 11, 2025. Blujepa and Nuzolvence approvals came within one day of each other and are similar in that both are indicated for ages 12 and older when standard of care treatment is contraindicated or when patients are intolerant or unwilling to use the first line of treatment. However, Blujepa requires two doses and patients must weigh 99 pounds, unlike Nuzolvene which requires only 77 pounds. Approval for Nuzolvence was based on phase III trials showing non-inferiority to ceftriaxone plus azithromycin, achieving a 90.9% microbiological cure rate versus 96.2% for standard therapy, including efficacy against drug-resistant strains. The pivotal study found common side effects including low white blood cell counts, headache, dizziness, nausea, and diarrhea, and labeling includes safety precautions and contraindications for allergies and certain drug interactions. The recommended dose is a single 3-gram packet mixed with water and taken orally within 15 minutes of preparation. Nuzolvence is expected to be available in the second half of 2026; however, the cost is not yet announced.
FDA Approves First Self-Administered Nasal Spray for Tachycardia
The FDA approved Milestone Pharmaceuticals’ Cardamyst™ (etripamil) nasal spray on Dec. 12, 2025, for the treatment of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) in adults. About two million Americans live with PSVT, an arrhythmia marked by sudden episodes of rapid heartbeats that can last hours and cause severe symptoms, anxiety, and significant disruption to daily life. Current PSVT management relies on intravenous (IV) calcium channel blockers, beta-blockers, and antiarrhythmics. Cardamyst is a novel calcium channel blocker self-administered intranasally, enabling on-demand use at symptom onset outside emergency settings. Approval was supported by the phase III RAPID trial, in which 64% of patients converted to sinus rhythm within 30 minutes compared with 31% on placebo (p<0.001), with a median conversion time of 17 minutes versus 54 minutes for placebo. The recommended dose is 70mg as two sprays (one per nostril), with a second dose after 10 minutes if needed with a maximum of 140mg in 24 hours. Common adverse events were mild and transient, including nasal discomfort and congestion. Milestone has pursued Cardamyst’s approval since 2023, overcoming two FDA setback,s including a refusal-to-file letter citing incomplete data and a later rejection over manufacturing controls. They are also studying Cardamyst in atrial fibrillation with rapid ventricular response (AFib-RVR), a condition affecting 10 to 12 million Americans. It is expected to be available in the first quarter of 2026 as two disposable nasal spray devices costing $1,649 per prescription. Here is the prescribing information.
Akeega Gets Label Expansion for Prostate Cancer
On Dec. 12, 2025, the FDA expanded Johnson & Johnson’s Akeega® (niraparib and abiraterone acetate) dual-action tablets, combined with prednisone, for the treatment of adult patients who have BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC). This marks the first FDA-approved precision medicine combination of a Poly ADP-ribose polymerase (PARP) inhibitor and an androgen receptor pathway inhibitor in the castration-sensitive setting. The regimen, given with an androgen deprivation therapy (ADT), significantly reduced the risk of radiographic progression or death by 54% and delayed symptomatic progression by 59% versus standard care in the phase III AMPLITUDE trial. The recommended dose is niraparib 200mg and abiraterone acetate 1,000mg orally once daily with prednisone 5mg daily, continued until disease progression or unacceptable toxicity. Prescribing information can be found here.
Addyi Gets Expanded Indication for Postmenopausal Women with HSDD
The FDA granted a new indication to Sprout Pharmaceuticals’ Addyi® (flibanserin 100mg) on Dec. 15, 2025, for the treatment of hypoactive sexual desire disorder (HSDD) in postmenopausal women under 65 years of age, expanding its original 2015 indication for premenopausal women. HSDD is a condition characterized by a persistent lack of sexual interest causing distress, impacting about 40% of women. Addyi activates serotonin 1A receptors and deactivates serotonin 2A receptors to affect levels of the neurotransmitters in the brain, increasing the desire for sex. The recommended dose is one tablet daily at bedtime. Addyi affects neurotransmitter levels in the brain. Drinking alcohol or using certain other prescription medications (including some antibiotics, some antiepileptic drugs, some antifungal drugs, some antivirals, and opioids) while taking Addyi can cause blood pressure decreases low enough to result in fainting. The once-daily bedtime dosing helps reduce the risk of hypotension and syncope. Therapy should be discontinued if no improvement is seen after eight weeks of treatment. Here is the updated prescribing information.
Enhertu Plus Perjeta Approved as First Line Therapy in HER2+ Breast Cancer
On Dec. 15, 2025, the FDA approved AstraZeneca and Daiichi Sankyo’s Enhertu® (fam-trastuzumab deruxtecan-nxki) in combination with Genentech’s Perjeta® (pertuzumab) for the first-line treatment of adults who have unresectable or metastatic human epidermal growth factor receptor 2 positive (HER2+) breast cancer, confirmed by an FDA-approved test. The regimen leverages Enhertu’s targeted delivery of chemotherapy directly to HER2-expressing cancer cells, combined with Perjeta’s HER2 blockade, offering improved efficacy and tolerability. Approval was based on the phase III DESTINY-Breast09 trial, which showed a 44% reduction in the risk of disease progression or death and a median progression-free survival of 40.7 months versus 26.9 months with the standard THP (taxane, trastuzumab, pertuzumab) regimen, alongside an objective response rate of 87% versus 81%. The recommended dosing is Enhertu 5.4mg/kg and Perjeta 840mg on day one of cycle one, followed by Enhertu 5.4mg/kg and Perjeta 420mg every three weeks. No new safety concerns were identified. Enhertu has boxed warnings and a patient Medication Guide. Enhertu also has approval for treating several additional indications and was first approved for HER2+ breast cancer as third-line treatment in 2019, followed by second-line therapy in 2022. The updated prescribing information is here.
Kymbee, a Branded Generic, Launches for Duchenne Muscular Dystrophy
Upsher-Smith Laboratories announced the launch of Kymbee™ (deflazacort) tablets, a branded generic of Emflaza® (deflazacort – PTC Therapeutics) indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients five years and older on Dec. 1, 2025. Deflazacort is an oral corticosteroid that decreases immune and inflammatory activity to treat Duchenne muscular dystrophy (DMD). Kymbee is available in 6mg, 18mg, 30mg, and 36mg tablet strengths. Kymbee joins other deflazacort formulations available, including generics, providing a US-manufactured option. Here is the prescribing information.
First Mavenclad Generic Launched
Apotex launched its generic cladribine tablets, referencing EMD Serono’s Mavenclad® for the treatment of relapsing forms of multiple sclerosis (MS) on Nov. 25, 2025. It can be used to treat relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS), but not for MS with clinically isolated syndrome. This is the first generic, and there are additional entrants expected in 2026. Mavenclad generated $752 million in US sales in 2024.
AstraZeneca Withdraws Andexxa After FDA Declines Full Approval Path
On Dec. 15, 2025, AstraZeneca announced the voluntary withdrawal of Andexxa® (andexanet alfa) effective Dec. 22, 2025, following the FDA’s decision not to convert its accelerated approval to traditional approval in December 2024. Andexxa, a recombinant modified human Factor Xa protein, is indicated for reversal of anticoagulation in patients on rivaroxaban (Xarelto®) or apixaban (Eliquis®) experiencing life-threatening or uncontrolled bleeding. Although the ANNEXA-I confirmatory trial demonstrated benefit primarily through reduced 12-hour hematoma volume, other clinically meaningful endpoints were similar between arms, and thrombosis rates were doubled versus usual care. The drug’s labeling includes black box warnings for arterial and venous thromboembolic events, ischemic events, cardiac arrest, and sudden death. After failing to reach alignment with the FDA on a feasible path to full approval, AstraZeneca will withdraw Andexxa from the US market.
New Subcutaneous Rybrevant Faspro Approved
On Dec. 17, 2025, the FDA approved Johnson & Johnson’s Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj), co-formulated with Enhanze® (Halozyme Therapeutics) technology, for SC administration across all previously approved indications of IV Rybrevant® for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation. This is the first SC option for these patients and reduces administration time from hours to approximately five minutes. Approval was based on the phase III PALOMA-3 trial, which demonstrated noninferior pharmacokinetics and comparable efficacy to IV delivery, with improved median progression-free survival (6.1 vs. 4.3 months) and overall survival benefit with a 38% reduction in the risk of death. The safety profile was largely consistent in the PALOMA-3 trial, except for systemic administration reactions. Subcutaneous dosing had a markedly lower rate of reactions, with 13% experiencing any-grade systemic administration reactions compared to 66% infusion-related reactions with IV delivery. The recommended dosing and administration for the SC formulation differ from the IV version; it is weight-based and given every two or three weeks with premedication as indicated. Safety warnings include hypersensitivity, interstitial lung disease, venous thromboembolism, dermatologic and ocular toxicities, and embryo-fetal risk. Here is the prescribing information.
FDA Grants Full Approval to Rubraca for Prostate Cancer Indication
On Dec. 17, 2025, the FDA granted traditional approval to Clovis Oncology’s Rubraca® (rucaparib) 600mg oral tablets for the treatment of adults with deleterious germline or somatic BRCA mutation-associated metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior androgen receptor-directed therapy. This decision converts the 2020 accelerated approval to full approval and was supported by the phase III TRITON3 trial, which demonstrated a significant improvement in radiographic progression-free survival (rPFS) for rucaparib versus the physician’s choice of therapy (enzalutamide, abiraterone, or docetaxel), with a median rPFS of 11.2 months compared to 6.4 months (P<.0001). Median overall survival was 23.2 months versus 21.2 months, though not statistically significant.
Recall
FreeStyle Libre 3 Sensor Recall On Nov. 24, 2025, Abbott Diabetes Care initiated a voluntary recall of select lots of the FreeStyle Libre 3 continuous glucose monitoring sensor. The recall was prompted by reports that some sensors may not accurately display low blood sugar readings, which could affect diabetes management and pose serious health risks, including potential injury or death. FreeStyle Libre 3 is FDA-approved for continuous glucose monitoring in people with diabetes. Patients and providers are encouraged to check affected lot numbers and serial numbers at www.freestylecheck.com and contact Abbott Diabetes Care or the dispensing pharmacy for replacement options. For more information on the recall, see here.