The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

Brexucabtagene autoleucel (Tecartus – Kite) has been approved by the FDA for treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). It was previously approved for treatment of relapsed or refractory mantle cell lymphoma. Tecartus is an individualized cellular product prepared from the patients own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. The CAR T-cell immunotherapy tisagenlecleucel (Kymriah) was approved in 2017 for treatment of relapsed or refractory...

High doses of various hormones have been used for many years to prevent pregnancy after unprotected coitus. Diethylstilbestrol (DES), a synthetic estrogen, was once approved for this purpose by the US Food and Drug Administration (Medical Letter 15:58, 1973), but no drug is now approved for such use. Ovral, an oral contraceptive containing 50 g of the estrogen ethinyl estradiol and 0.5 mg of the progestin norgestrel, has been recommended as a 'morning-after' pill by some physicians (RA Hatcher et al, Contraceptive Technology 1988-1989, 14th ed., New York:Irvington, 1988, page...

Vinorelbine (Navelbine - Burroughs Wellcome), a semisynthetic vinca alkaloid, has been approved by the US Food and Drug Administration for parenteral use in the treatment of advanced non-small-cell lung cancer (NSCLC). Various combinations of cisplatin (Platinol), vinblastine (Velban, and others), mitomycin (Mutamycin), ifosfamide (Ifex), etoposide (VePesid) and paclitaxel (Taxol) have been used previously for this indication.

Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.

The FDA has approved the subcutaneously injected monoclonal antibody dupilumab (Dupixent – Sanofi/Regeneron) for add-on maintenance treatment of patients ≥12 years old with moderate to severe asthma with an eosinophilic phenotype or with oral corticosteroid-dependent asthma. Dupilumab was approved earlier to treat adults with moderate to severe atopic dermatitis inadequately controlled with topical therapies.

The FDA has approved a fixed-dose combination of the amide local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam as an extended-release (ER) solution (Zynrelef – Heron) for single-dose, intraoperative, soft-tissue or periarticular instillation to provide postsurgical analgesia for up to 72 hours in adults undergoing foot and ankle, small-to-medium open abdominal, or lower extremity total joint arthroplasty surgical procedures.

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

Recent studies have caused concern about cardiomyopathy associated with doxorubicin (Adriamycin, and others), daunorubicin (Cerubidine, and others), idarubicin (Idamycin), mitoxantrone (Novantrone), and related anthracycline or anthraquinone anticancer drugs. Dexrazoxane (ADR-529, ICRF-187 - Adria), a piperazine derivative of ethylenediaminetetraacetic acid (EDTA), is now under investigation for prevention of this drug-induced cardiomyopathy.