Insights+: The US FDA New Drug Approvals in March 2023

Shots: The US FDA approved 6 NDAs and 1 BLA in March 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 26 novel products in 2023 In March 2023, the major highlights drugs were, Tafinlar + Mekinist approval for BRAF V600E low-grade glioma, Zynyz for metastatic or…

BySenior EditorApril 19, 2023

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Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome PharmaShots has compiled…

BySenior EditorMarch 23, 2023

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Insights+: The US FDA New Drug Approvals in February 2023

Shots: The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023 In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia A PharmaShots has compiled…

BySenior EditorMarch 15, 2023

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Insights+: EMA Marketing Authorization of New Drugs in January 2023

Shots: The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industry In January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitis PharmaShots has compiled a list of a total of 8 new drugs…

BySenior EditorFebruary 23, 2023

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Disease of the Month: Age-Related Macular Degeneration

Introduction: AMD, an eye disease that can cause of loss of eyesight/blur vision mostly in people ≥50 years of age and it is the leading cause of visual impairment worldwide. It occurs when the part of the retina (macula) is damaged. Patients lose their central vision and cannot see fine details The three stages of…

BySenior EditorFebruary 9, 2023

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Insights+: EMA Marketing Authorization of New Drugs in December 2022

Shots: The EMA approved 6 New Chemical Entity (NCE) and 6 Biologic Drugs in December 2022, leading to treatments for patients and advances in the healthcare industry In December 2022, the major highlights drugs were Pluvicto’s approval for progressive PSMA+ metastatic castration resistant prostate cancer, Dupixent for Prurigo Nodularis PharmaShots has compiled a list of…

BySenior EditorJanuary 24, 2023

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Insights+: EMA Marketing Authorization of New Drugs in November 2022

Shots: The EMA approved 4 New Chemical Entity (NCE) and 4 Biologic Drugs in November 2022, leading to treatments for patients and advances in the healthcare industry In November 2022, the major highlights drugs were Skyrizi's approval for active crohn's disease, Beyfortus for RSV lower respiratory tract disease PharmaShots has compiled a list of a…

BySenior EditorDecember 28, 2022

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Insights+: The US FDA New Drug Approvals in November 2022

The US FDA approved 1 NDAs and 6 BLA in November 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 73 novel products in 2022 In November 2022, the major highlights drugs were Imfinzi (durvalumab) + Imjudo (tremelimumab) approval for metastatic non-small cell lung cancer, Elahere for…

BySenior EditorDecember 15, 2022

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Insights+ Key Biosimilars Events of September 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of September, Fresenius Kabi’s Stimufend (biosimilar, pegfilgrastim) received the…

BySenior EditorOctober 6, 2022

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PharmaShots’ Key Highlights of Third Quarter 2022

The third quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include CVS Health acquired Signify Health for ~$8B, Amgen acquired Chemocentryx for ~$4B The third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo,…

BySenior EditorSeptember 29, 2022