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

Shots: The US FDA approved 8 NDAs and 1 BLA in January 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 9 novel products in 2023 In January 2023, the major highlights drugs were Rykindo (risperidone) approval for schizophrenia and bipolar 1 disorder, Brenzavvy (bexagliflozin) for type…

BySenior EditorFebruary 15, 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+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Shots: The 41st Annual J.P. Morgan Healthcare Conference took place on 09 – 12 January 2023 in San Francisco, CA, USA. It is the largest and most informative healthcare investment symposium in the industry, bringing together a cohort of industry leaders, emerging fast-growing companies, innovative technology creators, and members of the investment community The major announcement…

BySenior EditorJanuary 19, 2023

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PharmaShots’ Most Read News of 2022

The year 2022 has been a busy year for global pharma and biotech companies involved in M&A, option & licensing agreements, clinical trial results and gaining approvals. Our team has compiled a list of 30 most read life sciences news on PharmaShots in 2022 1. AVEO Entered into a Clinical Trial Collaboration with Merck KGaA to…

BySenior EditorJanuary 2, 2023

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PharmaShots’ Key Highlights of Fourth Quarter 2022

Shots: The fourth quarter of 2022 highlights approvals, multiple clinical trial results, and numerous deals. There are major alliances in this quarter which include Johnson & Johnson acquired Abiomed for ~$16.6B, Takeda entered into an agreement to acquire NDI-034858 from Nimbus Therapeutics for ~$6B In the fourth quarter of the year, BeiGene’s Brukinsa received EC’s…

BySenior EditorDecember 29, 2022

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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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Dr. Navdeep Tangri & Helen Yeh Shares Insights from the Data Presented at ASN Kidney Week 2022 on the Importance of Earlier Screening & Diagnosis of Chronic Kidney Disease

Shots: Dr. Navdeep spoke about the data presented at the ASN Kidney Week 2022 emphasizing on the urgent need for early screening of chronic kidney disease Helen Yeh talked about the treatment of CKD with Farxiga. She also focused on the patient support programs by AstraZeneca for the early diagnosis and screening of patients The…

BySenior EditorNovember 21, 2022

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

The US FDA approved 1 NDAs and 2 BLA in October 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 66 novel products in 2022 In October 2022, the major highlights drugs were Tecvayli’s approval for relapsed or refractory multiple myeloma, Furoscix for congestion in chronic heart…

BySenior EditorNovember 17, 2022

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Dr. Susana Banerjee, Medical Oncologist at The Royal Marsden Shares Insights from the SOLO-1 P-III Trial of Lynparza in Patients with BRCA Mutated Ovarian Cancer

Shots: Dr. Susan talked about the results from the SOLO-1 P-III trial of Lynparza in patients with BRCA mutated (BRCAm) newly diagnosed advanced ovarian cancer presented at ESMO’22 Dr. Susan also spoke about the overall survival of this 7-year follow-up study.The 7-year follow-up of SOLO-1 showed that olaparib provided a clinically meaningful improvement in OS…

BySenior EditorNovember 14, 2022

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

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

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

PharmaShots’ Most Read News of 2022

PharmaShots’ Key Highlights of Fourth Quarter 2022

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

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

Dr. Navdeep Tangri & Helen Yeh Shares Insights from the Data Presented at ASN Kidney Week 2022 on the Importance of Earlier Screening & Diagnosis of Chronic Kidney Disease

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

Dr. Susana Banerjee, Medical Oncologist at The Royal Marsden Shares Insights from the SOLO-1 P-III Trial of Lynparza in Patients with BRCA Mutated Ovarian Cancer

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