Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 3

Results For "CEP"

1785 News Found

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission
Biopharma | December 16, 2025

FDA accepts Sentynl Therapeutics CUTX-101 NDA resubmission

If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease


Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide
News | December 14, 2025

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed


DBT, BIRAC and CEPI renew cooperation agreement for vaccine development
R&D | December 05, 2025

DBT, BIRAC and CEPI renew cooperation agreement for vaccine development

DBT and BIRAC have partnered with CEPI since 2019, for cooperation on vaccine development for diseases of epidemic potential


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


Strides partners with Incepta to expand women's health access with WHO-prequalified contraceptive
Healthcare | October 18, 2025

Strides partners with Incepta to expand women's health access with WHO-prequalified contraceptive

Medroxyprogesterone acetate-SC is a three-month contraceptive that can be administered by healthcare workers or self-injected after appropriate training


FDA launches crackdown on deceptive drug advertising
Policy | September 16, 2025

FDA launches crackdown on deceptive drug advertising

The FDA is beginning rulemaking to close the “adequate provision” loophole


Fermenta receives CEP by EDQM for Vitadee 100 SD
Biotech | August 01, 2025

Fermenta receives CEP by EDQM for Vitadee 100 SD

Fermenta now becomes one of the only two companies globally to hold a CEP for this variant of Vitamin D3


Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL
Drug Approval | July 15, 2025

Milestone Pharmaceuticals announces FDA acceptance of response to Cardamyst nasal spray CRL

Milestone also announced the extension of its $75 million Royalty Purchase Agreement with RTW Investments


FDA accepts new drug application for Merck’s Doravirine/Islatravir
Drug Approval | July 11, 2025

FDA accepts new drug application for Merck’s Doravirine/Islatravir

The FDA set a target action date of April 28, 2026, under the Prescription Drug User Fee Act