FDA Approves 2026 iPLEDGE REMS Changes to Reduce Burden During Isotretinoin Use
On Feb. 9, 2026, the US Food and Drug Administration (FDA) approved significant modifications to the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) for isotretinoin, a medication that treats severe nodular acne. The iPLEDGE REMS program was implemented in 2005 to prevent fetal exposure to isotretinoin, a medication known to cause severe birth defects. The program is a single, shared FDA‑mandated safety system that requires prescribers, pharmacies and patients to follow strict protocols to ensure isotretinoin is used safely. This update is designed to reduce burden on patients, prescribers and pharmacies while safeguarding against fetal exposure. The changes allow greater flexibility around pregnancy testing after treatment begins, eliminate the prior waiting period tied to missed prescription pickups and reduce documentation requirements for certain patients. The revisions also clarify pharmacy responsibilities related to prescription handling and staff training, aiming to streamline access to isotretinoin without compromising safety.
Ozempic Tablets Approved as New Name and Doses for Oral Semaglutide, Previously Rybelsus
On Feb. 4, 2026, the FDA approved Novo Nordisk’s Ozempic® (semaglutide) oral tablets at doses of 1.5mg, 4mg and 9mg for use in adults with type 2 diabetes. Ozempic tablets are indicated to improve glycemic control as an adjunct to diet and exercise and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes at high cardiovascular risk. This oral formulation offers enhanced bioavailability, allowing the lower‑milligram strengths to achieve comparable therapeutic exposure and clinical benefit to the previously approved 3mg, 7mg and 14mg oral semaglutide doses, previously known as Rybelsus®. FDA approval was supported by a bioequivalence study and the existing clinical trial program for oral semaglutide, demonstrating a similar efficacy and safety profile to the original formulation. The new proprietary name is intended to simplify recognition of semaglutide‑based treatment options across oral and injectable presentations. The Ozempic tablet is expected to launch in the US in the second quarter of 2026, and patients currently receiving Rybelsus should continue therapy as prescribed until additional transition guidance is provided. Novo Nordisk has also submitted 25mg Ozempic tablets for use in adults with type 2 diabetes, with an FDA decision expected by the end of 2026. Here is the prescribing information.
Keytruda Gets New Indication in Platinum‑Resistant Ovarian Cancer
The FDA approved Merck’s Keytruda® (pembrolizumab), including Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa‑pmph), in combination with paclitaxel, with or without bevacizumab, for the treatment of adult patients with platinum‑resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express program death-ligand 1 (PD‑L1) and who have received one or two prior systemic therapies. Granted on Feb. 10, 2026, approval was based on improved progression‑free (PFS) and overall survival (OS) in PD‑L1–positive patients. In the study, patients treated with Keytruda plus paclitaxel, with or without bevacizumab had a median PFS of 8.3 months, compared with 7.2 months for those receiving placebo plus chemotherapy, a 28% reduction in the risk of disease progression or death. Median OS was 18.2 months in the Keytruda group versus 14 months in the placebo group, representing a 24% lower risk of death. The recommended dose of Keytruda is 200mg every three weeks or 400mg every six weeks, administered intravenously (IV) until disease progression, unacceptable toxicity, or for up to 24 months. Keytruda Qlex may be given subcutaneously (SC) at 395mg/4,800units every three weeks or 790mg/9,600units every six weeks under the same conditions. When administered on the same day, Keytruda or Keytruda Qlex should be given prior to paclitaxel, with or without bevacizumab. The FDA also approved the PD‑L1 IHC 22C3 pharmDx test (Agilent Technologies) as a companion diagnostic device. Updated prescribing information for Keytruda is available here, and prescribing information for Keytruda Qlex is available here.
FDA Approves Narcan Multipacks for High‑Volume Overdose Response Programs
On Feb. 12, 2026, the FDA approved Emergent BioSolutions’ over‑the‑counter Narcan® nasal spray (naloxone HCl) 4mg multipack for the emergency treatment of opioid overdose. The approval adds 6‑count and 24‑count multipack options intended for organizations distributing higher volumes of naloxone. The company said the multipacks will be available soon through NARCANDirect, its ordering and distribution platform. Emergent BioSolutions also noted the approval follows a January 2026 FDA clearance for a new carrying‑case packaging option.