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Results For "regulatory"

1133 News Found

Aptar’s nasal unidose system delivers FDA-approved neffy
News | August 19, 2024

Aptar’s nasal unidose system delivers FDA-approved neffy

This marks the first regulatory approval worldwide for nasally-delivered epinephrine


Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer
Drug Approval | August 17, 2024

Imfinzi approved in the US for the treatment of resectable non-small cell lung cancer

Based on AEGEAN Phase III trial results which showed Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone


Pfizer announces results of ABRYSVO for RSV in immunocompromised adults
Diagnostic Center | August 13, 2024

Pfizer announces results of ABRYSVO for RSV in immunocompromised adults

These results add to the growing body of evidence indicating a single dose of ABRYSVO provides strong immune protection against outcomes caused by RSV


Caplin Point announces completion of unannounced USFDA inspection
Drug Approval | August 11, 2024

Caplin Point announces completion of unannounced USFDA inspection

The inspection was concluded with zero observations


Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical
News | August 11, 2024

Merck to acquire investigational B-Cell depletion therapy from Curon Biopharmaceutical

CN201 is a next generation CD3xCD19 bispecific antibody that augments and diversifies Merck’s pipeline, with potential applications in B-cell malignancies and autoimmune diseases


IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr
News | August 10, 2024

IOL Chemicals and Pharmaceuticals posts Q1 FY25 PAT at Rs. 29.7 Cr

The company reported total income at Rs. 509.8 crore in Q1 FY25 as compared to Rs. 570.3 crore in Q1 FY24


Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.


32 projects completed under PLI Scheme for promotion of domestic manufacturing of Critical KSMs/DIs and APIs
Policy | August 10, 2024

32 projects completed under PLI Scheme for promotion of domestic manufacturing of Critical KSMs/DIs and APIs

Against targeted investment of Rs. 3,938 crore, investments worth Rs. 4,024 crores have been made under scheme


Gland Pharma posts 16% revenue growth in Q1 FY25
News | August 07, 2024

Gland Pharma posts 16% revenue growth in Q1 FY25

The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore


Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg
Drug Approval | August 06, 2024

Aurobindo Pharma receives USFDA approval for Estradiol Vaginal Inserts USP, 10 mcg

The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA