Opdivo Moves to the Front Line in Advanced Hodgkin Lymphoma

On March 20, 2026, the US Food and Drug Administration (FDA) approved Bristol Myers Squibb’s Opdivo® (nivolumab) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for the treatment of previously untreated stage III or IV classical Hodgkin lymphoma in adult and pediatric patients aged 12 years and older. An intravenous (IV) programmed death‑1 (PD‑1) inhibitor, Opdivo, was previously limited to use in relapsed or progressed classical Hodgkin lymphoma in post‑transplant or heavily pretreated patients. This approval establishes Opdivo plus chemotherapy as a new first‑line treatment option for advanced disease. Approval was based on a 58% reduction in the risk of disease progression or death compared with brentuximab vedotin plus AVD. At longer follow‑up (36.7 months), deaths occurred in 1.8% of patients receiving Opdivo plus AVD versus 3.4% in the comparator arm. Opdivo is administered intravenously on days one and 15 of each 28‑day cycle in combination with AVD for a maximum of six cycles, with primary granulocyte colony‑stimulating factor (G-CSF) prophylaxis recommended starting in cycle one. The recommended dose is 240mg for patients weighing at least 40kg, or 3mg/kg for pediatric patients weighing less than 40kg. The FDA also granted traditional approval to Opdivo for use in adults with relapsed or refractory classical Hodgkin lymphoma following autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin, or after three or more lines of systemic therapy that include autologous HSCT. These indications were previously granted accelerated approval in 2016 and 2017, respectively. Here is the updated prescribing information.

FDA Expands Restylane Indication to Include Temple Hollowing

The FDA approved Galderma’s Restylane^® Contour^™ (hyaluronic acid injectable gel) for the correction of temple hollowing in adults aged 21 years and older on March 22, 2026. This expands its prior indications for cheek augmentation and midface contour deficiencies. Approval was supported by statistically significant improvement versus no treatment, with 91% of patients classified as responders at three months and durability maintained in more than 85% of patients through 18 months. The product is administered by licensed aesthetic practitioners using a dual‑layer injection technique with needle and cannula, and safety findings were consistent with hyaluronic acid fillers, with mostly mild‑to‑moderate adverse events.

Age Limit Removed for Neffy Use

On March 27, 2026, the FDA approved an update to ARS Pharmaceuticals’ neffy^® 1mg (epinephrine nasal spray) prescribing information, removing the age requirement so that all children and adults weighing at least 33 pounds can use the product for the emergency treatment of Type I allergic reactions, including anaphylaxis. Previously, pediatric patients were required to be at least four years of age in addition to meeting weight criteria. Neffy is a needle‑free, prefilled nasal spray that delivers epinephrine through an alternative route to epinephrine injectors. In addition, the updated labeling recommends carrying Neffy in its blister packaging or in a dedicated carrying case, which the company plans to include with each prescription beginning this summer. Prescribing information has been updated here.

Drug Safety Communication

FDA Mandates New Seizure Warning for Parkinson’s Therapies Linked to Vitamin B6 Deficiency

On March 20, 2026, the FDA announced updates to prescribing information for all drug products containing vitamin B6 deficiency and associated seizures. The FDA’s action follows a safety review identifying 14 post‑marketing cases of seizures associated with vitamin B6 deficiency, including two fatalities, in patients receiving carbidopa/levodopa therapy. Approved for the treatment of Parkinson’s disease, levodopa’s conversion to dopamine depletes vitamin B6, while carbidopa further reduces functional vitamin B6 by binding its active form. The FDA now recommends that health care professionals assess baseline vitamin B6 levels prior to treatment, monitor levels during therapy, and supplement as clinically indicated. Labeling for all affected carbidopa/levodopa products will be revised accordingly.

Recall

Select IV Solutions Recalled

On March 17, 2026, Fresenius Kabi USA, LLC initiated a voluntary user‑level recall of select lots of 0.9% Sodium Chloride Injection, USP, 0.45% Sodium Chloride Injection, USP, and 5% Dextrose Injection, USP supplied in single‑dose freeflex® bags. The recall was prompted by reports that a blue Break‑off Part (BOP) attached to the infusion port may detach during handling. A health hazard evaluation determined the risk to patients and healthcare professionals to be low, and no adverse events have been reported for the affected lots. These IV solutions are commonly used to support hydration, electrolyte balance, and medication administration. Because they are delivered directly into the bloodstream, any defect affecting container or infusion‑port integrity could pose a potential risk of contamination, therapy interruption, or administration difficulties if not promptly addressed. For more information, see here.

FDA Actions to Modernize Biosimilar Development Issues Document

The FDA has advanced policy and guidance updates to modernize biosimilar development by emphasizing advanced analytical characterization and targeted clinical pharmacology, while reducing reliance on routine comparative efficacy trials, pharmacokinetic bridging and switching studies when scientifically appropriate. These updates are intended to lower development burden and support earlier and more consistent biosimilar competition in the US market without changing approval standards for safety and effectiveness. This Issues Document summarizes the latest FDA biosimilar development updates and highlights why these changes matter.