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ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care
In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…
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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…
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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…
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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…
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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…
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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 industry
In November 2023, the major highlighted drugs were Vyjuvek to Treat Dystrophic Epidermolysis Bullosa (DEB) and Vyvgart with Halozyme’s Enhanze for the treatment of…
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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 industry
In July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancer
PharmaShots has compiled a list…
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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…
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…
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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…

