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2477 News Found

Positive data for Roche multiple sclerosis injection
Drug Approval | April 17, 2024

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024


USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
News | April 17, 2024

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections


Novartis reports data from trial of IgA nephropathy treatment
Clinical Trials | April 16, 2024

Novartis reports data from trial of IgA nephropathy treatment

IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide


Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations
Drug Approval | April 14, 2024

Granules India’s Unit V facility in Visakhapatnam completes USFDA inspection with zero 483 observations

This facility manufactures APIs & formulations of oncology and non-oncology products.


CRISPR-based innovations drive $21 billion in pharmaceutical licensing deals over five years, reveals GlobalData
News | April 12, 2024

CRISPR-based innovations drive $21 billion in pharmaceutical licensing deals over five years, reveals GlobalData

The period from 2020 to 2022 witnessed a remarkable surge in deal worth


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


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