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

Results For "(FDA"

650 News Found

Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU
News | March 21, 2026

Bristol Myers Squibb scores major win with new Opdivo nods for Hodgkin Lymphoma in US, EU

These approvals represent a defining moment for people living with classical Hodgkin Lymphoma


Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA
Drug Approval | March 13, 2026

Shilpa Biologicals and mAbTree Biologics secure ODD from USFDA

Marks significant milestone for breakthrough biologic to treat rare blood cancers


Bayer expands MRXperion power injector capabilities with FDA nod
News | March 06, 2026

Bayer expands MRXperion power injector capabilities with FDA nod

The system also introduces Imaging Scanner Interface 2 (ISI2) capability, enabling direct communication between injector and scanner to improve exam coordination and operational efficiency


Granules India’s US packaging facility clears FDA inspection with zero observations
Packaging | March 06, 2026

Granules India’s US packaging facility clears FDA inspection with zero observations

The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices


NATCO announces launch of Pomalidomide capsules in US
News | March 05, 2026

NATCO announces launch of Pomalidomide capsules in US

It is also approved for?AIDS-related Kaposi sarcoma?after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma


Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing
News | February 28, 2026

Zydus hits Keytruda biosimilar milestone with successful FYB206 trial, targets USFDA filing

Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets


Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe
News | February 28, 2026

Eli Lilly and Incyte score key win for teens with severe alopecia areata in Europe

AA, a chronic immune disease, can cause extensive and unpredictable hair loss


FDA accepts Teva’s NDA for long-acting schizophrenia injection
Drug Approval | February 21, 2026

FDA accepts Teva’s NDA for long-acting schizophrenia injection

If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations


FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients
Drug Approval | February 21, 2026

FDA greenlights first all-oral, fixed-duration combo therapy for untreated CLL patients

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy


FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma
Drug Approval | February 17, 2026

FDA grants priority review to Bristol Myers Squibb's Iberdomide for multiple myeloma

Iberdomide has the potential to be the first approved CELMoD agent