The FDA has authorized use of the Valeda Light Delivery System (LumiThera), a multiwavelength photobiomodulation (PBM) device, to improve visual acuity in patients with dry age-related macular degeneration (AMD) who have best-corrected visual acuity (BCVA) of 20/32 to 20/70.

TThe FDA has licensed mResvia (Moderna), an mRNA respiratory syncytial virus (RSV) vaccine, for prevention of lower respiratory tract disease (LRTD) caused by RSV in adults ≥60 years old. It is the first mRNA vaccine to be licensed in the US for this indication. Two recombinant RSV vaccines, Arexvy and Abrysvo, are also available for prevention of RSV LRTD. Arexvy is approved for use in adults ≥50 years old. Abrysvo is approved for use in adults ≥60 years old and in pregnant women to prevent RSV LRTD in their infants.

Plenity (Gelesis), a nonsystemic oral superabsorbent hydrogel formulation of cellulose and citric acid is now available. It was cleared by the FDA in 2019 to aid in weight management together with diet and exercise in overweight and obese adults (BMI of 25-40 kg/m2). It is classified by the FDA as a device because the contents of the capsule are not absorbed systemically. Plenity is the first ingested, transient, space-occupying hydrogel to be marketed in the US and the only weight management treatment available by prescription for patients with a BMI of 25-30 kg/m2, regardless of...

The investigational monoclonal antibodies casirivimab and imdevimab (REGEN-COV – Regeneron) have been available in the US under an Emergency Use Authorization (EUA) since late 2020 for use together to treat mild to moderate COVID-19 in persons ≥12 years old who weigh ≥40 kg and are at high risk of progression to severe disease or hospitalization. The FDA has now expanded this EUA to allow use of the antibodies together for post-exposure prophylaxis of COVID-19 in such persons, if they are not fully vaccinated against COVID-19 or are unlikely to have an adequate immune response...

Balfaxar (Octapharma), a human plasma-derived four-factor prothrombin complex concentrate (PCC), has been approved by the FDA for rapid reversal of warfarin anticoagulation in adults who require an urgent surgical/invasive procedure. It is the second four-factor PCC to become available in the US; Kcentra, which has been available since 2013, is approved for the same indication and for urgent reversal of warfarin anticoagulation in adults with acute major bleeding. Balfaxar is marketed in Canada and Europe as Octaplex.

Lifileucel (Amtagvi – Iovance), a tumor-derived autologous T-cell immunotherapy, has received accelerated approval from the FDA for one-time treatment of adults with unresectable or metastatic melanoma previously treated with a programmed death receptor-1 (PD-1) inhibitor, and if BRAF V600 mutation-positive, a BRAF inhibitor with or without a mitogen-activated kinase (MEK) inhibitor. It is the first cellular therapy to be approved for use in solid tumors. Accelerated approval of lifileucel was based on objective response rates.

Femlyv (Millicent), an orally disintegrating tablet containing ethinyl estradiol and norethindrone acetate, has been approved by the FDA for prevention of pregnancy in females with a body mass index (BMI) ≤35 kg/m². It is the first hormonal contraceptive to become available in an orally disintegrating tablet formulation. Traditional oral and chewable tablets containing ethinyl estradiol and norethindrone acetate in a wide range of doses, including those found in Femlyv, have been available in the US for years.

On December 18, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Moderna mRNA-based vaccine for prevention of COVID-19 in persons ≥18 years old. The Pfizer-BioNTech mRNA-based vaccine received an FDA EUA for the same indication in persons ≥16 years old on December 11, 2020.

The FDA has approved Altuviiio (Sanofi), a von Willebrand Factor (VWF)-independent, recombinant factor VIII concentrate, for routine prophylaxis, on-demand treatment to control bleeding episodes, and perioperative management of bleeding in children and adults with hemophilia A. The manufacturer claims that Altuviiio, which was previously called efanesoctocog alfa, delivers normal to near-normal factor VIII levels for most of the week with once-weekly intravenous dosing.

Toripalimab-tpzi (Loqtorzi – Coherus Biosciences), a programmed death receptor-1 (PD-1)-blocking antibody, has been approved by the FDA for use in combination with cisplatin and gemcitabine for first-line treatment of recurrent locally advanced or metastatic nasopharyngeal carcinoma and for use as monotherapy for treatment of recurrent unresectable or metastatic nasopharyngeal carcinoma in adults with disease progression on or after platinum-based chemotherapy. It is the first immune checkpoint inhibitor to be approved in the US for treatment of nasopharyngeal carcinoma.