BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers

Shots: The US FDA has approved Tevimbra + Pt & fluoropyrimidine-based CT as a 1L treatment of inoperable or metastatic HER2- G/GEJ adenocarcinoma with PD-L1 (≥1) expression. Another BLA for 1L locally advanced unresectable or metastatic ESCC is under review Approval was based on P-III (RATIONALE-305) study of Tevimbra + CT vs PBO in patients…

ByDipanshu DixitDecember 26, 2024

INSIGHTS+

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

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2024 The US FDA approved a total of 14 drugs including 12 new molecular entities and 2 biologics leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was BeiGene’s Tevimbra for treating Advanced…

ByDipanshu DixitApril 15, 2024

News

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

Shots: BeiGene’s Tevimbra has received the US FDA’s approval as a monotx. to treat unresectable or metastatic esophageal squamous cell carcinoma (ESCC) after previous systemic chemotherapy (CT) excl. PD-(L)1 inhibitor. The US availability is anticipated in H2’24 The approval was supported by the P-III (RATIONALE 302) study assessing the safety & efficacy of Tevimbra vs…

ByDipanshu DixitMarch 14, 2024

News

BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

Shots: The MAA was based on the evaluation of NSCLC patients (n=1,499) in 3 P-III studies incl. (RATIONALE 307) for Tevimbra + carboplatin + paclitaxel/nab-paclitaxel vs CT (1L treatment for sq. NSCLC), (RATIONALE 304) for Tevimbra + pemetrexed + platinum-containing CT vs CT (1L treatment for non-sq. NSCLC) & (RATIONALE 303) for Tevimbra vs CT…

ByDipanshu DixitFebruary 27, 2024

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

Shots:The EMA approved 3 BLA while 6 New Chemical Entities with 1 recommendation and 1 acceptance in November 2023, leading to treatments for patients and advances in the healthcare industryIn November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…

BySenior EditorDecember 29, 2023

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

Shots:The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industryIn July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancerPharmaShots has compiled a list…

BySenior EditorAugust 24, 2023

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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 2023In 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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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 20221. 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 ~$6BIn 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 industryIn November 2022, the major highlights drugs were Skyrizi's approval for active crohn's disease, Beyfortus for RSV lower respiratory tract diseasePharmaShots has compiled a list of a…

BySenior EditorDecember 28, 2022

BeiGene’s Tevimbra Plus Chemotherapy Secures the US FDA’s Approval as a 1L Treatment of G/GEJ Cancers

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

The US FDA Grants Approval to BeiGene’s Tevimbra to Treat Advanced or Metastatic Esophageal Squamous Cell Carcinoma

BeiGene’s Tevimbra (tislelizumab) Receives CHMP’s Positive Opinion for the Treatment of Non-Small Cell Lung Cancer (NSCLC)

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

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

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

PharmaShots’ Most Read News of 2022

PharmaShots’ Key Highlights of Fourth Quarter 2022

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

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