The US FDA New Drug Approvals in June 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025 The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…

ByDipanshu DixitJuly 15, 2025

NEWS

AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Shots: AstraZeneca has reported P-III (BaxHTN) trial findings on baxdrostat in pts with uncontrolled hypertension on two antihypertensives & those with resistant hypertension on ≥3 drugs, incl. a diuretic The P-III (BaxHTN) trial evaluated baxdrostat (1 or 2mg) vs PBO on top of SoCs in 796 pts over 12wks. At Wk. 24, 300 pts on…

ByRidhi RastogiJuly 14, 2025

NEWS

Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041

Shots: Eolas Therapeutics has secured full development rights from AstraZeneca for AZD4041 to treat opioid use disorder (OUD) and other substance use disorders; terms remain confidential As per the agreement, Eolas will take full responsibility for AZD4041 under the existing IND and advance it to P-II trials with NIDA UG3 support, focusing on a patient-centered…

ByDipanshu DixitJuly 11, 2025

NEWS

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The EC has approved Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Approval was based on the P-III (NIAGARA) trial (n=1063) in MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

ByRidhi RastogiJuly 4, 2025

NEWS

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots: The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CT Approval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…

ByDipanshu DixitJune 26, 2025

NEWS

AstraZeneca Partners with CSPC Pharmaceuticals to Identify and Develop Small Molecule Across Chronic Indications

Shots: AstraZeneca & CSPC have partnered to discover & develop pre-clinical candidates for multiple targets across chronic diseases, incl. a pre-clinical oral small molecule for immunological diseases As per the deal, CSPC will receive $110M upfront as well as ~$1.62B in development & ~$3.6B in sales milestones with net sales-based single digit royalties, while AstraZeneca…

ByRidhi RastogiJune 16, 2025

NEWS

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

Shots: The EC has approved Calquence (acalabrutinib) + venetoclax ± Gazyva for the treatment of adults with 1L CLL; regulatory review is ongoing in other regions Approval was based on the P-III (AMPLIFY) trial assessing Calquence regimen with or without Gazyva vs chemoimmunotherapy (fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab) in treatment-naïve CLL pts without del(17p) or TP53 mutation Trial showed…

ByRidhi RastogiJune 6, 2025

NEWS

AstraZeneca Presents P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for G/GEJ Cancers at ASCO 2025

Shots: AstraZeneca has shared P-III (MATTERHORN) trial data assessing perioperative Imfinzi + FLOT (n=474) vs PBO + FLOT (n=474) in 948 pts with stage II-IVA G/GEJ cancers at ASCO 2025 Pts received Imfinzi (1500mg) + FLOT or PBO + FLOT for Q4W × 2 cycles before surgery followed by Imfinzi (2 cycles with FLOT CT + 10…

ByRidhi RastogiJune 2, 2025

NEWS

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Shots: The CHMP has recommended Imfinzi as a perioperative treatment of MIBC; regulatory review is ongoing in Japan & other regions Opinion was based on the P-III (NIAGARA) trial (n=1063) MIBC pts randomized to either neoadj. Imfinzi + CT before cystectomy followed by adj. Imfinzi or neoadj. CT with no further treatment after surgery …

ByRidhi RastogiMay 27, 2025

NEWS

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

Shots: Health Canada has granted conditional approval to Tagrisso for the treatment of pts with locally advanced, inoperable NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, whose disease progressed on or following Pt-based CRT Approval was based on P-III (LAURA) study assessing Tagrisso (80mg, QD, PO) vs PBO among adults (n=216)…

ByRidhi RastogiMay 22, 2025

The US FDA New Drug Approvals in June 2025

AstraZeneca Reports P-III (BaxHTN) Trial Results of Baxdrostat for Uncontrolled or Treatment Resistant Hypertension

Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041

AstraZeneca Reports the EC’s Approval for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

AstraZeneca Partners with CSPC Pharmaceuticals to Identify and Develop Small Molecule Across Chronic Indications

AstraZeneca’s Calquence Regimen Receives the EC’s Approval for 1L Chronic Lymphocytic Leukaemia (CLL)

AstraZeneca Presents P-III (MATTERHORN) Trial Data of Imfinzi as Perioperative Therapy for G/GEJ Cancers at ASCO 2025

AstraZeneca Reports the CHMP’s Positive Opinion for Perioperative Imfinzi to Treat Muscle-Invasive Bladder Cancer (MIBC)

AstraZeneca’s Tagrisso (Osimertinib) Secures Health Canada’s Conditional Approval to Treat Unresectable EGFR-Mutated NSCLC

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