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2716 News Found

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


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


Lupin launches first generic version of Oracea in US
News | April 10, 2024

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients


USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma
Drug Approval | April 06, 2024

USFDA approves Bristol Myers and 2seventy bio’s Abecma for triple-class exposed multiple myeloma

Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial


Enhertu approved in the US as first tumour-agnostic HER2-directed therapy
Drug Approval | April 06, 2024

Enhertu approved in the US as first tumour-agnostic HER2-directed therapy

Enhertu now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers


Aster DM Healthcare concludes separation of India and GCC businesses
Healthcare | April 05, 2024

Aster DM Healthcare concludes separation of India and GCC businesses

The company plans to add 1700 beds by FY27 through the organic route


Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data
Drug Approval | April 01, 2024

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024


Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer
Drug Approval | March 30, 2024

Truqap plus Faslodex approved in Japan for patients with advanced HR-positive breast cancer

First and only AKT inhibitor approved in Japan for breast cancer patients with specific biomarker alterations


EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer
Drug Approval | March 28, 2024

EC approves Merck’s Keytruda plus chemotherapy as neoadjuvant treatment for non-small cell lung cancer

Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results


Briefs: Alkem Laboratories and Zydus Lifesciences
Drug Approval | March 28, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant