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Results For "Food-and-Drug-Administration"

1014 News Found

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer
Drug Approval | February 20, 2025

Boehringer's zongertinib receives Priority Review from USFDA for the treatment of HER2 mutant advanced non-small cell lung cancer

Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved


Innocan Pharma granted first patent in India for its Liposomal CBD Injection
News | February 20, 2025

Innocan Pharma granted first patent in India for its Liposomal CBD Injection

Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market


GSK’s Penmenvy approved by FDA to help protect against MenABCWY
News | February 17, 2025

GSK’s Penmenvy approved by FDA to help protect against MenABCWY

Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)


FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy
Drug Approval | February 13, 2025

FDA approves Roche’s Evrysdi tablet as first and only tablet for Spinal Muscular Atrophy

Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries


FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL
Drug Approval | February 13, 2025

FDA approves Pfizer’s ADCETRIS combination regimen for the treatment of Relapsed/Refractory DLBCL

Approval is based on positive data from the Phase 3 ECHELON-3 trial


Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution
News | February 11, 2025

Lupin receives approval from USFDA for Ipratropium Bromide Nasal Solution

Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis


Briefs: Caplin Point Laboratories, Hikal and Cipla
Drug Approval | February 10, 2025

Briefs: Caplin Point Laboratories, Hikal and Cipla

Hikal Limited announces the completion of the US Food and Drug Administration (USFDA) inspection at its Jigani unit, Bengaluru


FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections
News | February 08, 2025

FDA approves EMBLAVEO for the treatment of adults with complicated intra-abdominal infections

EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA


FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness
Drug Approval | February 05, 2025

FDA approves Roche’s Susvimo as the first and only continuous delivery treatment diabetes-related blindness

Susvimo is the first and only continuous delivery treatment that offers an alternative to regular eye injections to treat diabetic macular edema (DME)


Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations
Drug Approval | February 03, 2025

Lupin announces closure of USFDA inspection at its Somerset facility with zero 483 observations

The inspection was carried out from January 28 to February 1, 2025