PDR Drug Update - January 2026

Reducing Vasomotor Symptoms in Menopause

Natural aging processes in women usually prompt the onset of menopause after the age of 40, as follicular functions in the ovaries lessen and estrogen levels decline. Certain medical procedures or surgeries can also be responsible for the onset of perimenopause and menopause. Experiences and symptoms (and their intensity) can vary widely among women; therefore, a range of treatment options exists. New advancements like non-hormonal therapy options help address the unmet needs of many female patients who must manage symptoms such as vasomotor and sleep disturbances.

Perimenopause is classified as the stage from which changes in the menstrual cycle are first recognized through twelve months after a woman has her final menstruation. It can be a multi-year transition, with the potential for a variety of symptoms. As estrogen levels drop, other hormones can also fluctuate. As a result, issues such as insomnia, thinning scalp hair, increased facial hair, fatigue, and vasomotor symptoms may be experienced. Vasomotor symptoms are often called hot flashes or hot flushes. They occur because hormones influence the brain's temperature control center. These flashes can be extreme, and are often accompanied by sweating, heart palpitations, rising adrenaline, and anxiety.

Typical assistance given to women who are experiencing the process of menopause involves hormone replacement therapy. By reintroducing hormones or hormone-like drugs, many symptoms can be negated. However, there are many women for whom taking hormones is not desired or possible. For example, hormone replacement therapy is not recommended for individuals who have a history of or who are at high risk for developing breast cancer.

For these women, non-hormonal therapies to help treat symptoms of menopause are preferred. Nearly three years ago, Veozah (fezolinetant) was introduced as the first neurokinin 3 (NK3) receptor antagonist to be approved by the FDA for the treatment of hot flashes due to menopause. The NK3 receptor is involved in how the brain regulates body temperature. Fezolinetant can block the overactivation of neurotransmitters that can lead to vasomotor issues. Now, a new drug has received FDA approval that targets both NK3 and neurokinin 1 (NK1), essentially recalibrating the entire thermoregulatory pathway in the body. The approval was given to Lynkuet (elinzanetant), indicated for the treatment of moderate-to-severe vasomotor symptoms due to menopause.

The clinical trials for elinzanetant demonstrated its efficacy and positive safety profile. It offers a significant reduction in the frequency and severity of hot flashes, with results as early as the first week of starting the medication. It was well tolerated in most patients, with generally mild side effects, such as headaches. Approval of new medications such as elinzanetant is important in bringing women more choices for treating the symptoms they experience with menopause. Ongoing trials for the drug are continuing, which will help determine the potential for it in prescribing to those who have breast cancer and sleep disturbances.

The research hopefully will lead to further approvals and more evidence-based options for women experiencing menopause, in order to offer flexibility with effective treatment and improve individualized care. Stay informed about emergent drug information, including treatment options for easing symptoms related to menopause, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Armlupeg

The FDA has approved Armlupeg (pegfilgrastim-unne) as biosimilar to Neulasta (pegfilgrastim). Armlupeg is indicated for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia; and for increasing survival in patients acutely exposed to myelosuppressive doses of radiation. Learn more about Armlupeg

Augmentin XR

The FDA has approved Augmentin XR (amoxicillin-clavulanate potassium) under the Commissioner's National Priority Voucher (CNPV) pilot program. The FDA's re-approval marks the first drug approved through the CNPV expedited pathway. Augmentin XR has been unavailable in the US since August 2011. Augmentin XR is indicated for the treatment of community-acquired pneumonia and acute bacterial sinusitis in adult and pediatric patients. Learn more about Augmentin XR

Breyanzi

The FDA has approved Breyanzi (lisocabtagene maraleucel), a CD19-directed chimeric antigen receptor T-cell therapy for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy. Learn more about Breyanzi

Cardamyst

The FDA has approved Cardamyst (etripamil) nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia to sinus rhythm in adults. Learn more about Cardamyst

Enhertu + Pertuzumab

The FDA has approved Enhertu (trastuzumab deruxtecan) in combination with pertuzumab for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer, as determined by an FDA-approved test. Learn more about Enhertu plus pertuzumab

Exdensur

The FDA has approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment of severe asthma characterized by an eosinophilic phenotype in adult and pediatric patients aged 12 years and older. Learn more about Exdensur

Itvisma

The FDA has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of children 2 years of age and older, teens, and adults living with spinal muscular atrophy with a confirmed mutation in the survival motor neuron 1 gene. Learn more about Itvisma

Jascayd

The FDA has approved Jascayd (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. Learn more about Jascayd

Lerochol

The FDA has approved Lerochol (lerodalcibep-liga) injection for subcutaneous use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia. Learn more about Lerochol

Myqorzo

The FDA has approved Myqorzo (aficamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms. Learn more about Myqorzo

Nuzolvence

The FDA has approved Nuzolvence (zoliflodacin) for oral suspension, a first-in-class, single-dose oral medication for the treatment of uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35kg. Learn more about Nuzolvence

Omisirge

The FDA has approved Omisirge (omidubicel-onlv) for the treatment of severe aplastic anemia. Learn more about Omisirge

Rubraca

The FDA has approved Rubraca (rucaparib) for the treatment of patients with a deleterious BRCA 1/2 mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy. Learn more about Rubraca

Rybrevant Faspro

The FDA has approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), the first subcutaneously administered therapy for patients with epidermal growth factor receptor-mutated non-small cell lung cancer. Rybrevant Faspro is approved across all indications of Rybrevant (amivantamab-vmjw). Learn more about Rybrevant Faspro

Voyxact

The FDA has granted accelerated approval of Voyxact (sibeprenlimab-szsi) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy at risk for disease progression. Learn more about Voyxact

Waskyra

The FDA has approved Waskyra (etuvetidigene autotemcel) for the treatment of Wiskott-Aldrich syndrome (WAS). Waskyra is indicated for pediatric patients six months and older and adults with WAS who have a mutation in the WAS gene and for whom hematopoietic stem cell transplantation is appropriate and no suitable human leukocyte antigen-matched related stem cell donor is available. Learn more about Waskyra

FDA New Indications

Akeega

The FDA has approved Akeega (niraparib and abiraterone acetate) plus prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. Learn more about Akeega

Blujepa

The FDA has approved Blujepa (gepotidacin) as an oral option for adult and pediatric patients from 12 years of age weighing at least 45kg who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae. Learn more about Blujepa

Imfinzi

The FDA has approved Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancers. Learn more about Imfinzi

Jaypirca

The FDA has approved Jaypirca (pirtobrutinib) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent Bruton tyrosine kinase inhibitor. Learn more about Jaypirca

Keytruda, Keytruda Qlex + Padcev

The FDA has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab/berahyaluronidase alfa-pmph) in combination with Padcev (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. Learn more about Keytruda and Keytruda Qlex plus Padcev

Uplizna

The FDA has approved Uplizna (inebilizumab-cdon) for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor and anti-muscle-specific tyrosine kinase antibody positive. Learn more about Uplizna

FDA New Formulations

Daybue Stix

The FDA has approved Daybue Stix (trofinetide) for oral solution, a dye- and preservative-free powder formulation of trofinetide for the treatment of Rett syndrome in adult and pediatric patients two years of age and older. Learn more about Daybue Stix

Orladeyo

The FDA has approved an oral pellet formulation of once-daily Orladeyo (berotralstat) for prophylactic therapy in pediatric patients aged 2 to <12 years with hereditary angioedema. Learn more about Orladeyo

FDA Recalls

MR7 Super 700000 Capsules

StuffbyNainax is voluntarily recalling all lots of MR7 Super 700000 capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared sildenafil and tadalafil. Learn more about the MR7 Super 700000 capsules recall

ReBoost and ClearLife Nasal Sprays

MediNatura is voluntarily recalling all lots of ReBoost Nasal Spray to the consumer level. The product has been found to contain yeast/mold and microbial contamination, with one species identified as Achromobacter, at levels above specifications. It is also recalling all lots of ClearLife Nasal Spray to the consumer level. The product has been found to contain microbial contamination that may be linked to Achromobacter at levels above specifications. Learn more about the ReBoost and ClearLife Nasal Sprays recalls

FDA Drug Safety Communications

Andexxa

Thromboembolic events, including serious and fatal outcomes, have occurred in patients treated with Andexxa (coagulation factor Xa (recombinant), inactivated-zhzo). The FDA considers the product's risks to outweigh its benefits. The FDA has communicated this position to the manufacturer, AstraZeneca, and the company has submitted a request to voluntarily withdraw the BLA for the product for commercial reasons. Additionally, the company has confirmed that it will end US commercial sales by December 22, 2025. Andexxa will no longer be manufactured for or sold in the US by AstraZeneca after December 22, 2025. Learn more about the update on the safety of Andexxa by AstraZeneca

January 2026