Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

Shots: The US FDA approved Myqorzo (aficamten) is now commercially available in the US for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms Myqorzo is a QD, oral cardiac myosin inhibitor available in 5, 10, 15, and 20 mg tablets and directly targets hypercontractility and LVOT obstruction…

ByPrince GiriJanuary 28, 2026

INSIGHTS+

2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe

Shots: EMA approvals in 2025 reinforce a biology-first regulatory standard, favoring mutation-exact, genotype-defined, and severity-weighted therapies that narrow indications, elevate rare diseases, and reward durability of benefit over rapid market expansion Convenience at the EMA is no longer cosmetic, it is integral to benefit–risk assessment, with oral, subcutaneous, and low-burden dosing strategies increasingly tied to adherence, long-term outcomes,…

ByDipanshu DixitJanuary 22, 2026

INSIGHTS+

The US FDA New Drug Approvals in December 2025

Shots: Innovation peaked in December 2025, as the FDA delivered a wave of approvals spanning cardiometabolic disease, infectious disease, respiratory immunology, rare hematologic disorders, and acute cardiovascular and neurologic conditions highlighting both scientific breadth and clinical precision Seven notable therapies crossed the regulatory finish line, including LIB Therapeutics’ Lerochol for LDL lowering, Innoviva’s Nuzolvence for gonorrhea, GSK’s Exdensur for asthma with eosinophilic phenotype, Cytokinetics’ Myqorzo…

ByDipanshu DixitJanuary 13, 2026

NEWS

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

Shots: The US FDA has approved Aptar’s Cardamyst (Etripamil), developed by Milestone Pharmaceuticals, for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults Cardamyst (Intranasal) is a Bidose (BDS) Liquid Nasal Spray System Aptar collaborated with Milestone Pharmaceuticals to design a custom polypropylene container closure system with an…

ByDipanshu DixitDecember 17, 2025

NEWS

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Shots: The US FDA has approved Lerochol as an LDL-C lowering therapy for adults with hypercholesterolemia, including HeFH; US launch as a PFS is expected in spring 2026, with an autoinjector later in 2026, while EMA approval is anticipated in Jun 2026 alongside additional global regulatory filings Approval was supported by the global P-III (LIBerate) trial, enrolling over 2,900 CVD patients and without…

ByDipanshu DixitDecember 12, 2025

NEWS

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis

Shots: Cardiawave has received the European CE Mark for its Valvosoft to treat Severe Symptomatic Aortic Stenosis (sSAS) Valvosoft delivers precise high-intensity ultrasound that induces non-thermal, mechanical energy to soften aortic valve leaflets tissues, restoring their mobility & improving anatomical & hemodynamic function Valvosoft was evaluated in the Valvosoft FIM Study (24mos.) & Pivotal Study…

ByRidhi RastogiDecember 5, 2025

NEWS

GE HealthCare to Acquire Intelerad for $2.3B

Shots: GE HealthCare has entered into an agreement to acquire Intelerad, expanding its cloud-enabled & AI-powered solutions portfolio As per the deal, GE HealthCare will acquire Intelerad for a purchase price of $2.3B in cash; closing is expected in H1’26 Acquisition will add Intelerad’s cloud-enabled radiology & cardiology imaging platforms & outpatient enterprise workflow solutions…

ByRidhi RastogiNovember 21, 2025

NEWS

Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline

Shots: Novartis has agreed to acquire Avidity Biosciences, strengthening its neuroscience pipeline with Avidity’s Antibody Oligonucleotide Conjugates (AOCs) platform & 3 late-stage programs As per the deal, Novartis will acquire Avidity for $72/share, valuing the company at ~$12B with an enterprise value of ~$11B; closing expected in H1’26 Before the merger, Avidity will transfer its early-stage precision…

ByRidhi RastogiOctober 27, 2025

NEWS

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Shots: Abbott has received European CE Mark for its Volt PFA System to treat pts with atrial fibrillation; commercialization has begun, with further expansion in EU markets expected by H2’25 Approval was based on CE Mark study in the EU & Australia, showing that the Volt achieved pulmonary vein isolation (PVI) in 99.1% veins with…

ByRidhi RastogiMarch 28, 2025

INSIGHTS+

Know Your Investor (March Edition): Qiming Venture Partners

Shots: In this reprise, we feature Qiming Venture Partners again, based on the investments in 2023. With more than 600 investments to date, Qiming boasts a strong portfolio of companies involved in Technology & Consumer and Healthcare In 2023, Qiming closed 38 funding rounds comprising 11 in the first quarter, 10 in the second, 11…

BySenior EditorMarch 26, 2024

Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

2025 EMA Drug Approvals Outlook: A Year of Intentional, Biology Led Medicine Across Europe

The US FDA New Drug Approvals in December 2025

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

LIB Therapeutics Receives the FDA Approval for Lerochol (Lerodalcibep-liga) for Adults with Elevated LDL Cholesterol

Cardiawave Receives CE Mark for Valvosoft to Treat Severe Symptomatic Aortic Stenosis

GE HealthCare to Acquire Intelerad for $2.3B

Novartis to Acquire Avidity Biosciences for ~$12B, Boosting its Neuroscience Pipeline

Abbott Secures European CE Mark for Volt PFA System to Treat Atrial Fibrillation

Know Your Investor (March Edition): Qiming Venture Partners

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