Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

NEWS

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Shots: The US FDA approved MSD's Idvynso (100mg doravirine/0.25mg islatravir; QD, PO) to treat HIV-1 in virologically suppressed adults (HIV-1 RNA <50 copies/mL) as a switch option for those on stable regimens with no prior treatment failure or doravirine resistance Approval was supported by the P-III trials, incl. Trial 052 (n=513), where pts switched from…

ByRidhi RastogiApril 22, 2026

NEWS

Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System

Shots: The US FDA has granted 510(k) clearance to Philips for its Spectral CT Verida system, an AI-powered detector-based spectral CT platform for diagnostic imaging Verida integrates always-on spectral imaging with AI-based deep learning reconstruction to enhance image quality, reduce noise, and improve diagnostic precision across radiology, cardiology, and oncology applications The system enables simultaneous…

ByPrince GiriApril 17, 2026

NEWS

LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

Shots: The US FDA has accepted LEO Pharma's sNDA for Anzupgo(delgocitinib) cream for the treatment of pediatric patients (12-17yrs.) with mod. to sev. chronic hand eczema (CHE); regulatory review is ongoing in the EU sNDA was backed by the P-III (DELTA TEEN) trial assessing Anzupgo (20mg/g, BID) vs cream vehicle in pediatric pts with CHE…

ByRidhi RastogiApril 16, 2026

NEWS

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Shots: The US FDA has approved Rapiblyk (landiolol) for use in pediatric pts (from birth to <18 years of age) with supraventricular tachycardia (SVT), expanding its use beyond adults Approval was supported by the LANDI-PED study (n=60), which showed >20% reduction in ventricular rate, demonstrating clinically meaningful heart rate control in this patient subgroup Rapiblyk…

ByRidhi RastogiApril 16, 2026

NEWS

Cala Reports the US FDA Clearance of Cala kIQ Plus System for Essential Tremor and Parkinson’s Disease

Shots: The US FDA has granted clearance to Cala kIQ Plus system, a wearable neurostimulation device, for the treatment of action hand tremor in essential tremor (ET) & Parkinson's disease (PD) The Cala kIQ device provides temporary relief of hand tremors in adults with essential tremor & Parkinson’s disease, incl. postural & kinetic tremors, using transcutaneous…

ByRidhi RastogiApril 16, 2026

NEWS

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

Shots: The US FDA has granted Breakthrough Device Designation to the urine-based Multi-Cancer Early Detection (MCED) test The non-invasive platform analyzes volatile organic compounds (VOCs) using spectroscopy & machine learning to detect multiple cancers from a single urine sample The test provides an alternative to blood-based screening, supporting scalable population screening, while the designation enables…

ByRidhi RastogiApril 15, 2026

NEWS

Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Shots: The US FDA has received the sBLA of Bizengri (zenocutuzumab-zbco) for the treatment of adults with advanced unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 (NRG1) gene fusion sBLA was supported by eNRGy study assessing Bizengri in pts with NRG1 fusion-positive cancers, incl. cholangiocarcinoma, showing an ORR of 36.8% & mDOR of 12.9mos. per BICR, in…

ByRidhi RastogiApril 15, 2026

NEWS

Eli Lilly to Acquire CrossBridge Bio for ~$300M

Shots: Eli Lilly has entered into a definitive agreement to acquire CrossBridge Bio, incl. its synergistic dual payload platform for the development of differentiated therapeutics As per the deal, Lilly will acquire CrossBridge Bio for ~$300M in cash, incl. an upfront payment & a subsequent milestone payment CrossBridge Bio is advancing CBB-120, a TROP2-targeting TOP1i/ATRi…

ByRidhi RastogiApril 15, 2026

INSIGHTS+

The US FDA New Drug Approvals in March 2026

Shots: Approval momentum accelerated in late March 2026, with the US FDA clearing five new therapies across hepatology, dermatology, rare genetic disorders, oncology, and endocrinology; highlighting both therapeutic breadth and meaningful clinical impact. Five notable therapies crossed the regulatory finish line: GSK’s Lynavoy for cholestatic pruritus in primary biliary cholangitis, Johnson & Johnson’s Icotyde for moderate-to-severe plaque psoriasis, Denali…

ByDipanshu DixitApril 14, 2026

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Merck Reports the US FDA Approval of Idvynso for Virologically Suppressed HIV-1 Infection

Philips Receives US FDA 510(k) Clearance for AI-Powered Spectral CT Verida System

LEO Pharma Reports the US FDA’s sNDA Acceptance of Anzupgo for Use in Children with Chronic Hand Eczema

AOP Health Reports the US FDA Approval Rapiblyk (Landiolol) for Pediatric Patients with Supraventricular Tachycardia

Cala Reports the US FDA Clearance of Cala kIQ Plus System for Essential Tremor and Parkinson’s Disease

TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Multi-Cancer Test

Partner Therapeutics Reports the US FDA sBLA Submission of Bizengri for NRG1 Fusion Positive Cholangiocarcinoma

Eli Lilly to Acquire CrossBridge Bio for ~$300M

The US FDA New Drug Approvals in March 2026

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