Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Shots: Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review The trial met its 1EP, showing superior improvement in peak oxygen…

ByRidhi RastogiMay 14, 2025

INSIGHTS+

The US FDA New Drug Approvals in April 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of April 2025 The US FDA has approved a total of 3 new drug including 1 new molecular entity and 2 Biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Johnson & Johnson’s…

ByDipanshu DixitMay 13, 2025

NEWS

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots: The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25 The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

NEWS

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

Shots: The US FDA has approved Teal Wand to screen cervical cancer at-home for women (25-65yrs.); commercially available in California by Jun 2025, with further expansion worldwide Approval was based on SELF-CERV study, which showed Teal Wand detected cervical precancer 96% of the time, with 94% participants preferring at-home screening test if it was as…

ByRidhi RastogiMay 12, 2025

NEWS

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…

ByRidhi RastogiMay 9, 2025

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FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advance to the planned PDUFA of Jun 30, 2025, which will be available in the US within a week as a co-pack Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200 mg,…

ByDipanshu DixitMay 9, 2025

NEWS

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Shots: The US FDA has accepted the Class 2 BLA resubmission of narsoplimab for the treatment of HSCT-associated thrombotic microangiopathy (TA-TMA), with PDUFA goal date assigned in late Sept 2025; EMA’s MAA filing expected by late Q2’25 The BLA resubmission incl. primary set of survival analyses, showing improved OS in TA-TMA pts, along with survival…

ByRidhi RastogiMay 7, 2025

NEWS

Merck Animal Health’s Mometamax Single Receives the US FDA’s Approval to Treat Dogs with Otitis Externa

Shots: The US FDA has approved Mometamax Single (gentamicin, posaconazole, & mometasone furoate otic suspension) to treat otitis externa in dogs; commercially available by the summer of 2025 Mometamax Single has shown favorable efficacy, with 80.5% resolution of clinical signs in dogs vs 19.6% with PBO Mometamax Single is a single-dose in-clinic treatment for otitis…

ByRidhi RastogiMay 5, 2025

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Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Shots: The US FDA has accepted NDA of oral Wegovy for chronic weight management & major adverse CV events risk reduction in adults with obesity or overweight & comorbidities (PDUFA: Q4’25) Submission was based on the P-III (OASIS 4) trial assessing oral Wegovy (25mg; OD) vs PBO over 64wks. (incl. 12wk. dose escalation & 7wk.…

ByRidhi RastogiMay 5, 2025

NEWS

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

Shots: The US FDA has approved 505(b)(2) NDA of Atzumi (STS101) nasal powder for the acute treatment of migraine with or without aura in adults Approval was based on a P-I PK trial & P-III (ASCEND) trial, both showing fast absorption, rapid high DHE levels, & sustained DHE plasma concentrations over time Atzumi utilizes SMART…

ByRidhi RastogiMay 1, 2025

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

The US FDA New Drug Approvals in April 2025

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Teal Health Reports the US FDA’s Approval of Teal Wand for Cervical Cancer Screening

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

FDA Grants Verastem Oncology’s Avmapki + Fakzynja Accelerated Approval for KRAS-Mutated Low-Grade Serous Ovarian Cancer (LGSOC)

Omeros Reports the US FDA’s Acceptance of Resubmitted BLA for Narsoplimab to Treat TA-TMA

Merck Animal Health’s Mometamax Single Receives the US FDA’s Approval to Treat Dogs with Otitis Externa

Novo Nordisk Reports the US FDA’s NDA Acceptance of Oral Wegovy for Weight Management

Satsuma Pharmaceuticals’ Atzumi (Dihydroergotamine) Nasal Powder Receives the US FDA’s Approval for Acute Treatment of Migraine

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