The US FDA New Drug Approvals in February 2026

Shots: Approval momentum strengthened in February 2026, with the US FDA clearing four new therapies across dermatology, psychiatry, and rare pediatric disorders highlighting both volume and therapeutic impact. Four notable therapies crossed the regulatory finish line, Acrotech Biopharma and Otsuka Pharmaceutical’s Adquey for mild-to-moderate atopic dermatitis, Vanda Pharmaceuticals’ Bysanti for acute bipolar I disorder and schizophrenia, Immedica Pharma’s Loargys for ARG1-D–related hyperargininemia, and Ascendis Pharma’s Yuviwel to improve growth in children with achondroplasia Overall, February 2026 reflected…

ByDipanshu DixitMarch 10, 2026

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The US FDA New Drug Approvals in January 2026

Shots: Approval numbers were lower, but the impact remained strong the FDA cleared one new drug in January 2026 versus three in January 2025, reflecting continued innovation in areas of high unmet need Zycubo from Sentynl Therapeutics was approved for pediatric Menkes disease, offering a targeted treatment for this rare, life-threatening genetic copper deficiency disorder Clinical results were striking, showing…

ByDipanshu DixitFebruary 10, 2026

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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

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EMA Marketing Authorization of New Drugs in December 2025

Shots: Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact. In December 2025, the EMA…

ByDipanshu DixitJanuary 20, 2026

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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

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EMA Marketing Authorization of New Drugs in March 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 1 New Chemical Entity in March 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Capvaxive to treat invasive pneumococcal disease PharmaShots has compiled a list of 3 drugs that have been…

ByDipanshu DixitApril 22, 2025

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A Complete Account of EMA Approvals in 2024

Shots: In 2024, EMA approved around 53 drugs in various therapy areas, ranging from cardiology, oncology, hematology, neurology, and dermatology to infectious diseases, vaccines, diagnostic agents, pneumology, nephrology, hepatology, ophthalmology, and endocrinology PharmaShots, in an illuminating report, brings a condensed analysis of the approved drugs with the most explored areas being Oncology, Hematology, Neurology, &…

ByDipanshu DixitMarch 6, 2025

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The US FDA New Drug Approvals in December 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of December 2024 The US FDA has approved a total of 10 new drugs including 4 new molecular entities and 6 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was BMS’ Opdivo Qvantig…

ByDipanshu DixitJanuary 14, 2025

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PharmaShots’ Key Highlights of Fourth Quarter 2024

Shots: The Fourth quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Roche's acquisition of Poseida Therapeutics for ~$1.5B This quarter also showcased multiple clinical trial results including Pfizer's P-III Study Data of Talzenna + Xtandi to treat mCRPC …

ByDipanshu DixitJanuary 13, 2025

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EMA Marketing Authorization of New Drugs in November 2024

Shots: The EMA’s CHMP has granted positive opinions to 3 Biologics and 2 New Chemical Entities in November 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were AbbVie’s Elahere to treat Ovarian Cancer and Pfizer’s Hympavzi for Hemophilia A and B PharmaShots has compiled a list of…

ByDipanshu DixitDecember 19, 2024

The US FDA New Drug Approvals in February 2026

The US FDA New Drug Approvals in January 2026

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

EMA Marketing Authorization of New Drugs in December 2025

The US FDA New Drug Approvals in April 2025

EMA Marketing Authorization of New Drugs in March 2025

A Complete Account of EMA Approvals in 2024

The US FDA New Drug Approvals in December 2024

PharmaShots’ Key Highlights of Fourth Quarter 2024

EMA Marketing Authorization of New Drugs in November 2024

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