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Latest Industry News - Page 266

Biocon Gets USFDA Approval for Everolimus Oral Suspension in Pediatric, Adult TSC

USFDA concludes inspection at Biocon Biologics Malaysia Insulins facility

Ruchika Sharma30 Sept 2024 1:15 PM IST
Karnataka: Biocon Biologics has announced that the US Food and Drug Administration (USFDA) has completed a cGMP inspection at the Company's...
USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

USFDA issues EIR for Piramal Pharma Ahmedabad facility

Ruchika Sharma30 Sept 2024 12:11 PM IST
Mumbai: Piramal Pharma has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for its...
Lalitpur Pharma Park

Zydus Lifesciences gets USFDA nod for prostate cancer drug Enzalutamide

Ruchika Sharma30 Sept 2024 11:15 AM IST
Ahmedabad: Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to manufacture...
AbbVie Loses India Patent Bid for Cancer Drug Venetoclax, Generics Set to Enter Market

AbbVie seeks USFDA accelerated approval for telisotuzumab vedotin for previously treated non small cell lung cancer

Ruchika Sharma29 Sept 2024 1:15 PM IST
North Chicago: AbbVie has announced submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for...
Bad Times for Sanofi Healthcare? Market Signals Suggest Growing Pressure

Sanofi, Regeneron get USFDA nod for Dupixent for COPD

Ruchika Sharma29 Sept 2024 12:30 PM IST
Paris: Sanofi has announced that the US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) as an add-on maintenance treatment...
CDSCO Panel Clears Bristol Myers Yervoy for Two New Cancer Indications

USFDA approves Bristol Myers Squibb Cobenfy for Schizophrenia treatment in adults

Ruchika Sharma29 Sept 2024 10:00 AM IST
Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has approved COBENFY (xanomeline and trospium...
CDSCO Panel Asks Pure and Cure Healthcare To Revise Phase III Protocol of Tapinarof Cream

Pure & Cure Healthcare gets CDSCO Panel nod to study Ferric Maltol Capsules 30 mg

Dr. Divya Colin28 Sept 2024 6:00 PM IST
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has granted permission to Pure...
Lupin rolls out constipation drug Prucalopride in US after USFDA nod

Upcoming 50 pharma manufacturing plants under PLI scheme to be completed in 2 years: Centre

Ruchika Sharma28 Sept 2024 4:52 PM IST
New Delhi: The Centre has informed that the 50 upcoming pharmaceutical manufacturing plants under the production-linked incentive (PLI) scheme...
Alembic Pharma secures USFDA approval for Travoprost Ophthalmic Solution

Alembic Pharma receives USFDA EIR for Oral solid formulation facility (F-1) at Panelav

Ruchika Sharma28 Sept 2024 4:37 PM IST
Vadodara: Alembic Pharma has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the...
USFDA Closes Inspection at Zydus Ankleshwar Unit-2 With Three Observations

USFDA issues three observations each on API, Finished Product side of Lupin Pithampur facility

Ruchika Sharma28 Sept 2024 12:15 PM IST
Mumbai: Lupin has announced that the United States Food and Drug Administration (USFDA) has issued three observations each on the API and...
Lupin Manufacturing Solutions, PolyPeptide Group forge long term Peptide alliance

Lupin arm ink pact with Celnova for distribution of Orphan Drug NaMuscla in Argentina, Colombia

Ruchika Sharma28 Sept 2024 11:10 AM IST
Mumbai: Global pharma major, Lupin Limited has announced that its subsidiary Lupin Atlantis Holdings SA has entered into a distribution agreement...
After 40 Years, USFDA Approves Vanda Pharmas Motion Sickness Drug Nereus

Alembic Pharma receives USFDA approval for schizophrenia drug Paliperidone Extended Release

Ruchika Sharma27 Sept 2024 4:40 PM IST
Mumbai: Alembic Pharmaceuticals Limited today announced that it has received final approval from the US Food & Drug Administration (USFDA)...
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Evaluation of Biologic Efficacy and Cost per NNT in Moderate-to-Severe Psoriasis: Indian Analysis

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