The US FDA New Drug Approvals in May 2026

Shots: The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases. Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP). Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

ByDipanshu Dixit3 hours ago

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LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Shots: The US FDA has granted 510(k) clearance & CLIA waiver to VELO system for highly sensitive PCR results for respiratory pathogens LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 respiratory season, with US commercial activities anticipated in 2026 VELO system allows multiplex PCR testing for respiratory…

ByRidhi RastogiFebruary 16, 2026

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Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

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Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

Shots: FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data…

ByRidhi RastogiAugust 28, 2025

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Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19

Shots: The US FDA has approved mNEXSPIKE (mRNA-1283) for active immunization against COVID-19 in individuals (≥12yrs.) with ≥1 underlying risk factor as defined by Centers for Disease Control and Prevention; regulatory review is ongoing in other regions Approval was based on P-III (NextCOVE) trial assessing mNEXSPIKE (10 or 50μg) vs Spikevax (mRNA-1273) in ~11,400 subjects…

ByRidhi RastogiJune 3, 2025

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Novavax’s NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19

Shots: FDA has approved the BLA for Nuvaxovid against COVID-19 in adults (≥65yrs.) & individuals (12-64yrs.) with at least one underlying condition increasing risk of sev. COVID-19 based on a P-III trial, showing favorable safety & efficacy; commercially available in US this fall pending strain selection at FDA VRBPAC meeting on May 22, 2025 FDA…

ByRidhi RastogiMay 20, 2025

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Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

Shots: The US FDA granted 510(k) clearance (previously granted with EUA in Dec’22) and CLIA waiver for point-of-care respiratory health test. The Visby Medical Respiratory Health Test is a rapid PCR test used to detect and differentiate between upper respiratory infections caused by influenza (Flu) A & B and SARS-CoV-2 (COVID-19) Under the…

ByRidhi RastogiFebruary 28, 2025

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CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

Shots: The EC has approved Kostaive (ARCT-154) for active immunization to prevent COVID-19 in subjects of age ≥18yrs in the EU & EEA states following CHMP positive opinion in Dec 2024 Approval was based on Kostaive's clinical data incl. P-I/II/III showing its efficacy & tolerability, plus P-III COVID-19 booster trial depicting superior immunogenicity vs…

ByDipanshu DixitFebruary 18, 2025

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AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots: The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain Sipavibart was…

BySenior EditorJanuary 9, 2025

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AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

Shots: The EMA’s CHMP has granted positive opinion to Kavigale for the prevention of COVID-19 in immunocompromised individuals (≥12yrs.). It was reviewed under the EMA’s accelerated pathway Kavigale consists of an antiviral human IgG1 mAb, sipavibart, as its API that offers passive protection against SARS-CoV-2 by targeting the spike protein's receptor-binding domain Sipavibart was discovered…

ByDipanshu DixitJanuary 9, 2025

The US FDA New Drug Approvals in May 2026

LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Pfizer and BioNTech’s Comirnaty Receives the US FDA Approval for Active Immunization Against COVID-19

Moderna’s mNEXSPIKE Receives the US FDA’s Approval to Protect Against COVID-19

Novavax’s NuvaxovidReceives the US FDA Approval for Active Immunization against COVID-19

Visby Medical Reports the US FDA Clearance and CLIA Waiver for Point-of-Care Respiratory Health Test

CSL and Arcturus Therapeutics Report the EC’s Approval of Kostaive Against COVID-19

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

AstraZeneca and RQ Biotechnology Reports the CHMP’s Positive Opinion of Kavigale (Sipavibart) to Prevent COVID-19 in Immunocompromised Individuals

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