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Results For "observations"

259 News Found

Granules Pharmaceuticals concludes USFDA audit with three minor observations
News | January 31, 2022

Granules Pharmaceuticals concludes USFDA audit with three minor observations

The audit is a PAI for two of its product applications filed from this facility


U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations
Biotech | September 26, 2021

U.S. FDA completes inspection of Biocon Biologics, Malaysia with six observations

The company does not expect the outcome of this inspection to impact its plans


U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations
News | September 20, 2021

U.S. FDA concludes inspection of Lupin’s Goa facility with seven observations

The company said in a regulatory filing that it was confident of addressing the observations satisfactorily


AngioDynamics gets FDA nod for RELIEF trial to evaluate NanoKnife for enlarged prostate treatment
Medical Device | June 19, 2026

AngioDynamics gets FDA nod for RELIEF trial to evaluate NanoKnife for enlarged prostate treatment

Study will assess the safety and effectiveness of irreversible electroporation as a minimally invasive treatment option for benign prostatic hyperplasia (BPH)


We plan to invest nearly $100 million in new infrastructure, biologics and AI-driven drug discovery,: Akhil Ravi, CEO, Aurigene
interviews | June 16, 2026

We plan to invest nearly $100 million in new infrastructure, biologics and AI-driven drug discovery,: Akhil Ravi, CEO, Aurigene

Since 2022, we have grown threefold and our growth story is built on scale, scientific innovation and deep customer partnerships


Parexel to showcase AI, real-world evidence and patient-centric innovations at DIA 2026
Clinical Trials | June 12, 2026

Parexel to showcase AI, real-world evidence and patient-centric innovations at DIA 2026

Company experts to participate in eight sessions covering AI-powered clinical development, regulatory innovation, oncology research, and patient engagement


Granules Pharmaceuticals receives USFDA EIR for Chantilly facility
News | June 03, 2026

Granules Pharmaceuticals receives USFDA EIR for Chantilly facility

This facility plays an important role in Granules’ global manufacturing and supply network


Morepen Labs posts strong Q4 FY26 net profit
News | May 28, 2026

Morepen Labs posts strong Q4 FY26 net profit

For the full year, standalone gross revenue crossed Rs. 1,700 crore


Jubilant Pharmova posts 14% FY26 revenue growth to Rs. 8,280 crore amid margin pressure
News | May 22, 2026

Jubilant Pharmova posts 14% FY26 revenue growth to Rs. 8,280 crore amid margin pressure

Q4FY26 revenue climbs 19% to Rs. 2,290 crore as CDMO sterile injectables, radiopharma and generics businesses drive growth momentum


CARBOGEN AMCIS Shanghai site clears unannounced NMPA GMP inspection
News | May 07, 2026

CARBOGEN AMCIS Shanghai site clears unannounced NMPA GMP inspection

Successful inspection outcome strengthens company’s regulatory compliance and manufacturing standards in China