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

NEWS

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…

ByRidhi RastogiApril 14, 2026

NEWS

Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Shots: The US FDA has granted full approval to Filspari (sparsentan) to reduce proteinuria in pts (≥8yrs.) with focal segmental glomerulosclerosis (FSGS) without nephrotic syndrome Approval was based on the global P-III (DUPLEX) trial assessing Filspari vs irbesartan in 371 pts (8–75 yrs.) with biopsy-proven or genetic FSGS, following a 2wk. washout, with dose titration…

ByRidhi RastogiApril 14, 2026

NEWS

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

Shots: FDA has accepted BLA for I-DXd under the RTOR & Project Orbis program, granting priority review for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after Pt-based CT (PDUFA: Oct 10, 2026) BLA was based on the P-II (IDeate-Lung01) study assessing I-DXd (IV, Q3W) in…

ByRidhi RastogiApril 14, 2026

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

Protaryx Medical Secures FDA Clearance for its Transseptal Access Device

Travere Therapeutics Reports FDA Full Approval of Filspari for Proteinuria Reduction in FSGS

Daiichi Sankyo and Merck Receives FDA’s Priority Review for Ifinatamab Deruxtecan (I-DXd) to Treat ES-SCLC

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