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USFDA completes inspection of Lupin's Dabhasa facility with no observations
Drug Approval | April 13, 2024

USFDA completes inspection of Lupin's Dabhasa facility with no observations

The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations


Pfizer announces positive results from Phase 3 Study of Abrysvo
Clinical Trials | April 12, 2024

Pfizer announces positive results from Phase 3 Study of Abrysvo

ABRYSVO met its trial primary endpoints in adults aged 18 to 59 with an increased respiratory syncytial virus (RSV) disease risk.


Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer
Clinical Trials | April 11, 2024

Roche obtains CE Mark for first companion diagnostic to identify patients with HER2-low metastatic breast cancer

Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2


KRAZATI in Combination with Cetuximab demonstrates targeted treatment option for KRAS G12C- colorectal cancer
Clinical Trials | April 11, 2024

KRAZATI in Combination with Cetuximab demonstrates targeted treatment option for KRAS G12C- colorectal cancer

Late-breaking data to be featured in an oral presentation at the American Association for Cancer Research (AACR) annual meeting on Monday, April 8 and highlighted as part of the official meeting press program


NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana
Drug Approval | April 10, 2024

NATCO Pharma receives warning letter from USFDA for facility in Kothur, Telangana

The company will respond to the Warning Letter within the stipulated timelines


Shivalik Rasayan’s API facility gets 7 observations from USFDA
Drug Approval | April 10, 2024

Shivalik Rasayan’s API facility gets 7 observations from USFDA

These observations are procedural in nature and will be responded within the stipulated time


Eugia Steriles gets 3 observations from USFDA for injectable facility
Drug Approval | April 07, 2024

Eugia Steriles gets 3 observations from USFDA for injectable facility

The observations are procedural in nature and will be responded to within the stipulated time


Cipla Patalganga facility gets 6 USFDA observations
Drug Approval | April 07, 2024

Cipla Patalganga facility gets 6 USFDA observations

The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.


Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData
Drug Approval | April 06, 2024

Pfizer’s Velsipity UK approval will raise competition in ulcerative colitis market, says GlobalData

The approval marks a significant milestone for the American pharmaceutical company in the field of UC