FDA Approves Novel Non‑Steroidal Topical Option for Atopic Dermatitis

On Feb. 12, 2026, the US Food and Drug Administration (FDA) approved Acrotech Biopharma’s Adquey^™ (difamilast 1%) ointment, a topical non‑steroidal phosphodiesterase‑4 (PDE4) inhibitor for the treatment of mild‑to‑moderate atopic dermatitis in adult and pediatric patients aged two years and older. Adquey is designed for twice‑daily topical application, offering a non‑steroidal option to address inflammation and pruritus associated with eczema. Approval was supported by trials showing a significantly greater proportion of patients who achieved Investigator’s Global Assessment (IGA) success at week four compared with the vehicle. The safety profile was consistent across trials, with nasopharyngitis reported as the most common adverse reaction occurring at 6%. Launch timing and cost have not yet been disclosed. Here is the prescribing information.

Filkri Approved as Biosimilar to Neupogen

Accord BioPharma received FDA approval for Filkri® (filgrastim‑laha) injection, a biosimilar to Neupogen® (filgrastim – Amgen), on Jan. 15, 2026. Filkri is a recombinant, DNA‑derived granulocyte colony‑stimulating factor (G‑CSF) that stimulates neutrophil production and supports neutrophil recovery. Labeled indications include decreasing infection incidence manifested by febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of fever, reducing time to neutrophil recovery and fever duration following induction or consolidation chemotherapy in acute myeloid leukemia (AML), reducing duration of neutropenia and related sequelae after myeloablative chemotherapy followed by bone marrow transplantation, reducing incidence and duration of sequelae of severe chronic neutropenia (congenital, cyclic, or idiopathic) and increasing survival following acute exposure to myelosuppressive radiation doses (hematopoietic syndrome of acute radiation syndrome). The approval was supported by two randomized studies in healthy adults evaluating pharmacokinetics (PK) and pharmacodynamics (PD) in one study, and safety and immunogenicity in both studies, compared with reference Neupogen. Doses, which differ according to the condition being treated, may be injected intravenously (IV) or subcutaneously (SC). Filkri is supplied as single-dose prefilled syringes in 300 mcg/0.5mL and 480 mcg/0.8mL strengths. Cost and launch information are not yet available. Four other Neupogen biosimilars, Zarxio^™ (filgrastim-sndz – Sandoz), Nivestym^™ (filgrastim-aafi – Pfizer), Releuko^® (filgrastim-ayow – Amneal/Kashiv Biosciences), and Nypozi^™ (filgrastim-txid – Tanvex BioPharma) are currently available on the market. Here is the prescribing information.

FDA Approves Monthly Dosing for Rybrevant Faspro

On Feb. 17, 2026, Johnson & Johnson announced the FDA approved a simplified once-monthly (every four weeks) dosing schedule for Rybrevant Faspro™ (amivantamab and hyaluronidase‑lpuj) when administered in combination with oral Lazcluze® (lazertinib) for the first-line treatment of adults who have locally advanced or metastatic non‑small cell lung cancer (NSCLC) harboring epidermal growth factor (EGFR) receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA‑approved test. Rybrevant Faspro is an SC coformulation containing amivantamab, a bispecific EGFR-directed and mesenchymal epithelial transition (MET) receptor-directed antibody, plus hyaluronidase, that is administered SC in the abdomen over approximately five minutes with recommended premedication. Under the updated regimen, patients receive weekly weight-based injections during the first four weeks and may transition to monthly dosing beginning at week five. Approval was based on the PALOMA-2 study, which showed that the monthly regimen delivered a high objective response rate in patients with previously untreated, EGFR-mutated advanced NSCLC and offered a fivefold reduction in administration-related reactions. For full prescribing details, see here.

Expanded Wakix Indication for Children with Cataplexy

On Feb. 13, 2026, Harmony Biosciences’ Wakix® (pitolisant) received an expanded approval from the FDA. It is now approved for the treatment of cataplexy in pediatric patients six years of age and older with narcolepsy. Wakix is a selective histamine 3 (H₃) receptor antagonist/inverse agonist that was originally approved in August 2019 to treat adults with excessive daytime sleepiness (EDS) caused by narcolepsy. In October 2020, the label was updated to treat cataplexy in adults with narcolepsy, and in June 2024, Wakix was approved to treat EDS in pediatric patients six years of age and older with narcolepsy. Wakix is supplied as 4.45mg and 17.8mg tablets. Pediatric patients should start with 4.45mg once daily for the first week of treatment. The dose should be increased to 8.9mg once daily in Week 2 and titrated up to 17.8mg once daily in Week 3. This is the maximum dose for patients weighing less than 40kg (88 pounds). Patients weighing 40kg or more can increase their dosage to a maximum of 35.6mg once daily beginning Week 4. Wakix should be taken each morning upon waking. Here is its updated prescribing information.

Venclexta and Calquence Combination Approved for Chronic Lymphocytic Leukemia

On Feb. 20, 2026, AbbVie and Genentech’s Venclexta^® (venetoclax) was approved for use in combination with AstraZeneca’s Calquence^® (acalabrutinib) for the treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL). In the phase III clinical trial that led to the approval, the Venclexta-Calquence combination significantly reduced the risk of disease progression or death by 35% compared to chemoimmunotherapy. Venclexta is a B-cell lymphoma-2 (BCL-2) inhibitor, and Calquence is a Bruton’s tyrosine kinase (BTK) inhibitor. The approval marks the first all-oral, fixed-duration combination regimen approved for previously untreated patients with CLL. Both drugs are also approved for other cancers. Updated prescribing information for Venclexta can be found here, and updated prescribing information for Calquence can be found here.

Recall

One lot of Adbry was recalled

On Feb. 12, 2026, LEO Pharma initiated a voluntary US recall of Adbry^® (tralokinumab ldrm) 300 mg/2mL single dose autoinjector. The recall was prompted by the identification of particulate matter in a single unit from the affected lot, which laboratory testing determined to be wool fiber, raising concerns for potential patient exposure to foreign material. Adbry is approved for the treatment of moderate‑to‑severe atopic dermatitis in adult and pediatric patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. For recall information, see here.