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7496 News Found

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency
Drug Approval | November 16, 2024

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters


Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM
Drug Approval | November 16, 2024

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial


Solvay and Pantys join forces to advance menstrual health and sustainability
Healthcare | November 15, 2024

Solvay and Pantys join forces to advance menstrual health and sustainability

Donation drive in São Paulo aims to support 250 young women’s health and environmental responsibility


AstraZeneca invests US$ 3.5 billion in R&D and manufacturing in US
News | November 14, 2024

AstraZeneca invests US$ 3.5 billion in R&D and manufacturing in US

This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs


Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules
Drug Approval | November 11, 2024

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension


Zydus Wellness Q2 FY25 sales up 12% at Rs. 490.7 Cr
News | November 11, 2024

Zydus Wellness Q2 FY25 sales up 12% at Rs. 490.7 Cr

Net profit for the quarter grew by 254.2 per cent and stood at Rs. 20.9 crore


Akums Drugs and Pharmaceuticals posts Q2 FY25 adjusted PAT at Rs. 66.7 Cr
News | November 11, 2024

Akums Drugs and Pharmaceuticals posts Q2 FY25 adjusted PAT at Rs. 66.7 Cr

For Q2, Akums reported a consolidated total income of Rs. 1,046.6 crore


USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI
News | November 11, 2024

USFDA classifies Biocon Biologics’ Biocon Park in Bengaluru as VAI

The inspection scope had included six separate Biologics manufacturing units comprising of four Drug Substance and two Drug Product manufacturing plants


Granules India’s Unit V facility secures USFDA EIR with NAI status
Drug Approval | November 10, 2024

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit