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Results For "FDA"

2190 News Found

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer
News | February 05, 2026

AstraZeneca & Daiichi Sankyo gain priority review for Datroway in hard-to-treat breast cancer

The FDA’s regulatory decision is expected in Q2 2026 under the Prescription Drug User Fee Act (PDUFA)


Lupin launches Topiramate ER capsules in US
News | February 05, 2026

Lupin launches Topiramate ER capsules in US

Topiramate Extended-Release Capsules are bioequivalent to the reference listed drug (RLD), Trokendi XR Extended-Release Capsules of Supernus Pharmaceuticals


Novo Nordisk weathers pricing pressure, bets big on oral Wegovy
News | February 05, 2026

Novo Nordisk weathers pricing pressure, bets big on oral Wegovy

Operating profit fell 1% in Danish kroner to DKK 127.7 billion but rose 6% at constant exchange rates


SPARC announces receipt of priority review voucher associated with Sezaby approval
News | February 04, 2026

SPARC announces receipt of priority review voucher associated with Sezaby approval

A PRV is a tradable voucher granted by the FDA to encourage the development of new treatments for rare pediatric diseases


Lonza posts CHF 6.5 billion in 2025 sales, marks strong profit growth
News | January 30, 2026

Lonza posts CHF 6.5 billion in 2025 sales, marks strong profit growth

Excluding Vacaville-related business, organic CER sales growth reached the low-teens with improved CORE EBITDA margins, in line with Lonza’s CDMO Organic Growth Model


Eyestem moves closer to blindness breakthrough with phase 2 trial green light
R&D | January 29, 2026

Eyestem moves closer to blindness breakthrough with phase 2 trial green light

The early-stage trial demonstrated an excellent safety profile alongside clinically meaningful improvements in visual acuity


Yugap Wellness bolsters scientific leadership with Dr Satish Singh appointment
People | January 24, 2026

Yugap Wellness bolsters scientific leadership with Dr Satish Singh appointment

A PhD in Pharmaceutical Sciences, Dr Singh has led global regulatory audits, product validations, and quality systems spanning therapeutic formulations, dietary supplements, and functional foods


Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline
News | January 23, 2026

Dr Reddys Laboratories consolidated Q3 FY26 PAT drops to Rs. 1209.8 Cr, expands global pipeline

The company has posted net profit of Rs. 4,064.9 crore for the 9 months period ended December 31, 2025


AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder
Biotech | January 20, 2026

AGC Biologics powers commercial launch of its life-changing gene therapy for rare childhood immune disorder

Waskyra is an ex vivo gene therapy that uses patients’ own CD34+ hematopoietic stem and progenitor cells, genetically engineered with a lentiviral vector