EMA Marketing Authorization of New Drugs in September 2025

Shots: The EMA’s CHMP has granted approvals to 5 Biologics and 5 new chemical entities in September 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug, Merck’s Enflonsia, has Adopted Positive Opinion for RSV Prevention in Infants PharmaShots has compiled a list of 9 drugs that have been…

ByDipanshu DixitOctober 21, 2025

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EMA Marketing Authorization of New Drugs in August 2025

Shots: The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV PharmaShots has compiled a list of 4…

ByDipanshu DixitSeptember 16, 2025

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New Drug Designations: July 2025

Shots:    PharmaShots’ Designation Report offers a concise overview of the latest drug and device designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA. The July 2025 edition covers designations awarded to 47 drugs and 3 medical devices, comprising 23 small molecules, 9 biologics, 8 cell and gene therapies, and…

ByRidhi RastogiAugust 26, 2025

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EMA Marketing Authorization of New Drugs in July 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer PharmaShots has compiled a list of 13 drugs…

ByDipanshu DixitAugust 19, 2025

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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

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A Complete Account of FDA Approvals in 2024

Shots:In 2024, around 50 new drugs were approved by the US FDA across several indicationsPharmaShots, in an enlightening report, brings a summarized analysis of the approved drugs. The most explored section remains Oncology, Hematology, Dermatology, and CardiologyFor the complete report with analysis, reach out to us at connect@pharmashots.com While you embraced the new…

ByDipanshu DixitFebruary 5, 2025

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The US FDA New Drug Approvals in October 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of October 2024 The US FDA has approved a total of 4 new drugs including 2 new molecular entities and 2 biologics leading to the treatment of patients and advances in the healthcare industry The major highlighted drugs were Pfizer’s Hympavzi for…

ByDipanshu DixitNovember 12, 2024

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Insights+: The US FDA New Drug Approvals in July 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2024 The US FDA approved a total of 2 new drugs including 1 new molecular entity and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Eli Lilly’s Kisunla for…

ByDipanshu DixitAugust 13, 2024

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Insights+: The US FDA New Drug Approvals in June 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2024 The US FDA approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was Ipsen’s Iqirvo for the treatment…

ByDipanshu DixitJuly 16, 2024

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Insights+: The US FDA New Drug Approvals in May 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2024 The US FDA approved a total of 3 new drugs including 2 new molecular entities and 1 biologic leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Amgen’s Imdelltra for the treatment…

ByDipanshu DixitJune 18, 2024

EMA Marketing Authorization of New Drugs in September 2025

EMA Marketing Authorization of New Drugs in August 2025

New Drug Designations: July 2025

EMA Marketing Authorization of New Drugs in July 2025

The US FDA New Drug Approvals in July 2025

A Complete Account of FDA Approvals in 2024

The US FDA New Drug Approvals in October 2024

Insights+: The US FDA New Drug Approvals in July 2024

Insights+: The US FDA New Drug Approvals in June 2024

Insights+: The US FDA New Drug Approvals in May 2024

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