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Results For "BLA"

349 News Found

Samson Clinical completes patient recruitment for clinical trial of male-pattern baldness drug
Clinical Trials | November 17, 2025

Samson Clinical completes patient recruitment for clinical trial of male-pattern baldness drug

AGA affects up to 80 per cent of men across their lifetime and remains one of the most common and most psychologically challenging forms of hair loss


Hormone therapy for menopause gets green light from FDA
News | November 14, 2025

Hormone therapy for menopause gets green light from FDA

The FDA is initiating removal of the boxed warnings following a comprehensive review of the scientific literature


FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma
Drug Approval | November 12, 2025

FDA grants Orphan Drug Designation for Tinostamustine in malignant glioma

Tinostamustine is an investigational drug with a potential first-in-class mechanism combining bifunctional alkylating activity and pan histone deacetylase (HDAC) inhibition


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


IPP organises webinar on
News | November 05, 2025

IPP organises webinar on "Transforming Formulation R&D: Data, Digitalization and Beyond" on November 6, 2025

Speakers are: Dr. Alok Khullar, Senior Technology Leader, Pidilite Industries; Dr. Kamlesh Pai Fondekar, Head - R&D, Godrej Agrovet; Dr. Hiten Mehta, Head - R&D (Chlor-Alkali), Aditya Birla Chemicals; Dr. Anil Kumar Soni, Head - Application Development, R&D, Clariant Chemicals India; Dr. Rupak Paul, Deputy General Manager – Formulation, Rallis India; Dr. Manish M. Khandagale, Senior Field Application Specialist, Revvity Signals; and Pravin Prashant, Executive Editor, Indian Pharma Post


Advances in genetic testing, fertility preservation, and ART are reshaping reproductive care across India: Dr. Umesh N Jindal, Director, Jindal IVF
interviews | October 31, 2025

Advances in genetic testing, fertility preservation, and ART are reshaping reproductive care across India: Dr. Umesh N Jindal, Director, Jindal IVF

Dr. Jindal reflects on bridging accessibility gaps between urban and rural regions, the ethical and emotional aspects of family building, and how initiatives like adoption facilitation centers align with his lifelong mission to help couples realize the dream of parenthood


FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma
Drug Approval | October 29, 2025

FDA grants fast track status to Heidelberg Pharma’s Amanitin-based ADC candidate for multiple myeloma

The Fast Track Designation was supported by nonclinical data as well as clinical results from the ongoing Phase I/IIa trial evaluating the safety and tolerability


Relmada therapeutics appoints Dr. Max Kates to propel NDV-01 toward phase 3
People | October 13, 2025

Relmada therapeutics appoints Dr. Max Kates to propel NDV-01 toward phase 3

Phase 3 program for NDV-01 in non-muscle invasive bladder cancer expected to begin in the first half of 2026