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Touchlight unveils next-gen circular DNA portfolio for advanced gene therapies
Biotech | November 10, 2025

Touchlight unveils next-gen circular DNA portfolio for advanced gene therapies

The expanded mbDNA portfolio delivers enhanced stability, reduced immunogenicity, and broad compatibility with gene insertion and expression technologies


Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'
Drug Approval | November 10, 2025

Biohaven disappointed as rare disease therapy faces FDA setback 'despite promising results'

The FDA setback highlights ongoing tensions between patient needs, regulatory processes, and the use of real-world evidence in evaluating treatments for rare diseases


Caplin Point Laboratories reports Q2 FY26 consolidated PAT at Rs. 154.45 Cr
News | November 09, 2025

Caplin Point Laboratories reports Q2 FY26 consolidated PAT at Rs. 154.45 Cr

Caplin Point Laboratories has reported total income of Rs. 564.41 crore during the period ended September 30, 2025


Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Drug Approval | November 08, 2025

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers


Alembic announces USFDA final approval for Dasatinib Tablets
Drug Approval | November 08, 2025

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets


Alembic receives FDA final approval for Sumatriptan Injection USP
Drug Approval | November 08, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine


Bayer's finerenone approved in India for heart failure
Drug Approval | November 06, 2025

Bayer's finerenone approved in India for heart failure

The expanded approval allows Kerendia to be prescribed to heart failure patients with a LVEF of 40% or more


FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency
Drug Approval | November 06, 2025

FDA approves UCB’s Kygevvi for rare genetic mitochondrial disease TK2 deficiency

Kygevvi combines two pyrimidine nucleosides, doxecitine and doxribtimine, which act by integrating deoxycytidine and deoxythymidine into skeletal muscle mitochondrial DNA


Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg
Drug Approval | November 05, 2025

Zydus receives FDA’s tentative approval for Budesonide delayedrelease capsules, 4 mg

Budesonide is indicated for mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in adults and children 8 years of age and olde