Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Shots: The US FDA has accepted NDA of gadoquatrane (0.04mmol Gd/kg body weight) for contrast-enhanced MRI of the CNS & other body regions (OBR) in adults & pediatric pts incl. neonates; MAA was submitted to MHLW & EMA with further filings planned in other regions NDA was supported by the QUANTI clinical program, which incl.…

ByRidhi RastogiAugust 27, 2025

NEWS

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots: The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussions Trial met its 1EP of improved MG-ADL total score, showing…

ByRidhi RastogiAugust 27, 2025

NEWS

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The US FDA has approved Dawnzera (donidalorsen; 80mg SC, Q4W/Q8W) as a prophylactic treatment against attacks in pts (≥12yrs.) with hereditary angioedema; available in the US in coming days Approval was based on P-III (OASIS-HAE) trial & OASISplus OLE study, where P-III showed 81% fewer monthly HAE attacks over 24wks. (87% from 2nd dose) &…

ByRidhi RastogiAugust 22, 2025

NEWS

Rhythm Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Setmelanotide to Treat Acquired Hypothalamic Obesity

Shots: The US FDA has accepted sNDA of setmelanotide for the treatment of conditions associated with acquired hypothalamic obesity (PDUFA: Dec 20, 2025); Type II variation MAA is under the CHMP’s review sNDA & MAA were supported by global P-III (TRANSCEND) trial (N=120) assessing setmelanotide (n=81) vs PBO (n= 39) in 49 adults & 71 pediatric…

ByRidhi RastogiAugust 21, 2025

NEWS

ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Shots: ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic…

ByRidhi RastogiAugust 19, 2025

NEWS

Tonix Pharmaceuticals’ Tonmya Receives the US FDA’s Approval for Fibromyalgia

Shots: The US FDA has approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults; commercially available in Q4’25 Approval was based on 2 P-III (RELIEF & RESILIENT) trial assessing Tonmya vs PBO in 503 & 457 pts, respectively in the US, where pts started on Tonmya 2.8mg & increased the dose…

ByRidhi RastogiAugust 19, 2025

NEWS

Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC

Shots: Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…

ByDipanshu DixitAugust 18, 2025

NEWS

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Shots: Myra Vision received the US FDA conditional IDE approval to initiate its ADAPT study evaluating Calibreye Titratable Glaucoma Therapy (TGT) surgical system for glaucoma The IDE trial will evaluate the safety and efficacy of Calibreye TGT surgical system in ~70 refractory glaucoma pts with 12mos. primary effectiveness endpoint Calibreye System allows ophthalmologists to control…

ByRidhi RastogiAugust 13, 2025

NEWS

Insmed Reports the US FDA’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The US FDA has approved Brinsupri (10 & 25mg) for treating NCFB pts (≥12yrs.); it is now available in the US. MAA is under EMA & MHRA review with a Japan filing planned in 2025 & potential launches in 2026 pending approvals Approval was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial…

ByRidhi RastogiAugust 13, 2025

INSIGHTS+

The US FDA New Drug Approvals in July 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025 The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Regeneron’s Lynozyfic, securing…

ByDipanshu DixitAugust 12, 2025

Bayer Reports the US FDA’s NDA Acceptance of Gadoquatrane for Contrast-Enhanced MRI

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Ionis Reports the US FDA’s Approval of Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Rhythm Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Setmelanotide to Treat Acquired Hypothalamic Obesity

ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Tonix Pharmaceuticals’ Tonmya Receives the US FDA’s Approval for Fibromyalgia

Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC

Myra Vision Receives FDA Conditional IDE Approval for Calibreye TGT System to Treat Glaucoma

Insmed Reports the US FDA’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

The US FDA New Drug Approvals in July 2025

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