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Results For "NDA"

4220 News Found

Contineum MS drug stumbles in mid-stage trial
Clinical Trials | November 24, 2025

Contineum MS drug stumbles in mid-stage trial

Topline results from the Phase 2 VISTA trial show that PIPE-307 did not meet its primary or secondary efficacy endpoints


Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets
Drug Approval | November 24, 2025

Marksans Pharma Inc. receives USFDA approval for Loperamide Hydrochloride Tablets

Loperamide Hydrochloride is an anti-diarrheal medication used to control symptoms of acute and chronic diarrhoea


FDA investigates fatal case linked to rare blood disorder drug Adzynma
News | November 24, 2025

FDA investigates fatal case linked to rare blood disorder drug Adzynma

Adzynma, approved for both adults and children with cTTP, is a recombinant enzyme therapy designed to replace the deficient ADAMTS13 enzyme


Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy
News | November 24, 2025

Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy

Paxton alleges the companies marketed Plavix as a reliable defense against heart attacks, strokes, and blood clots while failing to disclose evidence that the drug could be ineffective or virtually useless for many people


Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER
Drug Approval | November 23, 2025

Biocon Pharma gets FDA nod for arthritis drug Tofacitinib ER

Tofacitinib extended-release tablets are a Janus kinase inhibitor indicated for Rheumatoid Arthritis


ACG unveils patent-clean laminate ‘DryPod’ to shake up moisture-protection market
R&D | November 23, 2025

ACG unveils patent-clean laminate ‘DryPod’ to shake up moisture-protection market

The company says the innovation delivers stronger moisture protection for highly sensitive drug molecules


FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
Drug Approval | November 23, 2025

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy


AstraZeneca to invest $2 billion in Maryland manufacturing expansion
News | November 22, 2025

AstraZeneca to invest $2 billion in Maryland manufacturing expansion

The multibillion-dollar Maryland expansion is part of AstraZeneca’s sweeping $50 billion global investment plan


Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial
Clinical Trials | November 21, 2025

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration