News about Drug Discovery & Development

Gland Pharma Secures USFDA Approval for Ready-to-Use Vasopressin Injection

The product is bioequivalent and therapeutically equivalent to the reference drug Vasostrict. Vasopressin is indicated for adults with vasodilatory shock who remain hypotensive despite adequate fluid resuscitation and catecholamine support.

Drug Discovery & Development | 27/08/2025 | By Darshana

Abbott Introduces FreeStyle Libre 2 Plus: Continuous Glucose Monitoring Without Fingersticks

Abbott, a global healthcare leader, has launched the FreeStyle Libre 2 Plus sensor in India, a device that delivers automatic glucose readings every minute directly to a user’s smartphone. The innovation aims to provide people living with diabetes greater confidence, precision, and ease in managing their condition.

Drug Discovery & Development | 22/08/2025 | By Darshana |  229

Stealth BioTherapeutics' Elamipretide NDA Resubmission Accepted for Review by US FDA

Stealth BioTherapeutics has announced that the US FDA has accepted for review its resubmitted New Drug Application for elamipretide to treat Barth syndrome, with a planned goal date of September 26, 2025.

Drug Discovery & Development | 22/08/2025 | By Mrinmoy Dey |  133

Thermo Fisher to Boost India's Biopharma Manufacturing with New Genome Valley Facilities

Thermo Fisher Scientific has announced major investments to strengthen India’s biopharma infrastructure, unveiling plans to establish two state-of-the-art facilities in Hyderabad’s Genome Valley by the end of 2025. The announcement was made during the Biopharma Conclave 2025, where company leaders engaged with government, industry, and academia.

Drug Discovery & Development | 21/08/2025 | By Darshana |  521

MedImpact to Launch Affordable Unbranded Biosimilar Ustekinumab-aekn in 2026

With specialty drug costs rising and many pharmacies closing, MedImpact’s strategy introduces a new sourcing model that provides pharmacies with access to lower prices while giving payers more flexibility and control over healthcare expenses. Importantly, this approach will extend beyond MedImpact’s own clients, offering broader industry-wide benefits.

Drug Discovery & Development | 20/08/2025 | By Darshana |  163

Gland Pharma Secures USFDA Approval for Norepinephrine Bitartrate in 5 Percent Dextrose Injection Bags

Gland Pharma Ltd. has received USFDA approval for its generic Norepinephrine Bitartrate in 5 percent Dextrose Injection, securing First-to-File status with 180 days of exclusivity in the US market.

Drug Discovery & Development | 16/08/2025 | By Mrinmoy Dey |  182

Hemispherian Secures FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1

Hemispherian AS has received FDA clearance for its IND application to begin a Phase 1 trial of GLIX1, a first-in-class small molecule targeting DNA repair vulnerabilities in glioblastoma and other solid tumours.

Drug Discovery & Development | 05/08/2025 | By Mrinmoy Dey |  189

EuMentis Therapeutics Secures US FDA Clearance of IND Application for EM-221

EuMentis Therapeutics has received FDA clearance to initiate a Phase 2 clinical trial of EM-221, its novel PDE10A inhibitor, for the treatment of schizophrenia.

Drug Discovery & Development | 31/07/2025 | By Mrinmoy Dey |  165

PharmNXT Acquires DTR to Bring European Bioprocess Manufacturing Expertise to India

In a major boost to India’s biopharmaceutical manufacturing landscape, Pune-based startup PharmNXT Biotech has acquired Ireland-based Defined Tubing Routing (DTR), a globally recognised innovator in advanced bioprocess tubing solutions.

Drug Discovery & Development | 28/07/2025 | By Darshana |  196

Godavari Biorefineries Secures Chinese Patent for Novel Anti-Cancer Molecule

Godavari Biorefineries Ltd., through its biotech arm Sathgen Therapeutics, has been granted a Chinese patent for its novel anti-cancer molecule HYDROXY-1,4-NAPHTHALENEDIONE.

Drug Discovery & Development | 22/07/2025 | By Mrinmoy Dey |  190