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3126 News Found

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


Alvotech and Teva get US FDA approval of Selarsdi
Drug Approval | April 17, 2024

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva


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.


Briefs: Sun Pharma and Kimia Biosciences
News | April 14, 2024

Briefs: Sun Pharma and Kimia Biosciences

Sun Pharma's Dadra facility receives OAI status from US FDA


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


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


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


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


Asahi Kasei Bioprocess and Axolabs partner to accelerate oligonucleotide therapeutics development
News | April 11, 2024

Asahi Kasei Bioprocess and Axolabs partner to accelerate oligonucleotide therapeutics development

The partners will collaborate to build a cutting-edge oligonucleotide cGMP manufacturing facility


Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg
Drug Approval | April 10, 2024

Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly