Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 149

Results For "NDA"

4846 News Found

Roche provides update on astegolimab in chronic obstructive pulmonary disease
Clinical Trials | July 21, 2025

Roche provides update on astegolimab in chronic obstructive pulmonary disease

The phase III ARNASA study did not meet the primary endpoint of a statistically significant reduction in the AER at 52 weeks


AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer
Clinical Trials | July 21, 2025

AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer

Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Bristol Myers Squibb announces topline Results from Phase 3 Independence trial for Reblozyl
Clinical Trials | July 19, 2025

Bristol Myers Squibb announces topline Results from Phase 3 Independence trial for Reblozyl

Reblozyl is a standard of care for the first-line treatment of anemia without previous erythropoiesis stimulating agent use


Concord Biotech announces successful completion EU GMP inspection at its API facility
News | July 18, 2025

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance


Vimta Labs Q1 FY26 PAT climbs to Rs. 18.89 Cr
News | July 18, 2025

Vimta Labs Q1 FY26 PAT climbs to Rs. 18.89 Cr

Vimta Labs has reported total income of Rs. 99.31 crores during the period ended June 30, 2025


Kenvue collaborates with API to launch India’s first cough clinics
Healthcare | July 18, 2025

Kenvue collaborates with API to launch India’s first cough clinics

Aims to support healthcare practitioners with evidence-based cough categorization tools that enable choosing the right molecules for effective & targeted relief from cough


Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2
Drug Approval | July 18, 2025

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively


SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally
Drug Approval | July 17, 2025

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards