Search Results

You searched for : FDAApprovalNews  

FDA authorizes monoclonal antibody therapy for emergency use in some patients 12 and older

The authorization is specifically for those with mild-to-moderate Covid-19, who are at risk of getting much sicker...
May 27

Unichem gets US FDA approval for Atenolol and Chlorthalidone Tablets

Another ANDA approval for Unichem...
Nov 30

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE (setmelanotide)

First-ever Therapy for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency...
Nov 28

Alembic Pharmaceuticals receives USFDA Tentative Approval for Palbociclib Capsules for Breast Cancer

Alembic now has a total of 135 ANDA approvals (117 final approvals and 18 tentative approvals) from USFDA....
Nov 10

BioXcel Therapeutics FDA Clearance of IND for Phase 2 Trial with BXCL501

BXCL50 is indicated for the treatment of agitation associated with Delirium...
Oct 27

Protagonist Therapeutics receives orphan drug designation from the EMA for PTG-300 in polycythemia vera

Protagonist Therapeutics has previously received orphan drug designation for the treatment of polycythemia vera from US FDA...
Oct 22

Astellas Pharma received US FDA approval for the treatment of primary mitochondrial myopathies

U.S. FDA grants fast track designation for ASP0367/MA-0211, a selective PPARδ modulator being developed for the treatment of primary mitochondrial myopathies ...
Oct 21

Ezra receives US FDA clearance for prostate cancer artificial intelligence

Ezra's Prostate AI is the first to ever be cleared by the FDA for prostate and lesion segmentation using AI ...
Oct 20

Regeneron’s Antibody cocktail REGN-EB3 (Inmazeb) is first FDA-Approved treatment for Ebola

First FDA approved antibody treatment for Ebola...
Oct 19

Bristol Myers Squibbs get FDA approval for Opdivo and Yervoy : Malignant Pleural Mesothelioma

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA ...
Oct 03

FDA grants IND Approval for Stemedica's itMSC Therapy for COVID-19 Patients

The study will enrol up to 40 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo...
Sep 29

FDA Grants AT-007 Pediatric Rare Disease Designation and Orphan Designation for treatment of PMM2-CDG

PMM2-CDG is a debilitating rare disease causes multiple organ failure and severe disability, resulting in approximately 20% mortality in the first four years of ...
Sep 26

Gyroscope Therapeutics Granted FDA Fast Track Designation for GT005

...
Sep 23

Genocea announces FDA acceptance of GEN-011 IND Application

...
Sep 23

Preparation products of Yiling Pharma approved by FDA for launch in the US market

Receives ANDA for Lisinopril and Acylovir tablets...
Sep 21

Vaxart announces FDA clearance of IND application for oral COVID-19 Vaccine

Oral Covid vaccine gains ground...
Sep 18

Roche receives FDA approval for CINtec PLUS Cytology test in preventing cervical cancer

Cervical cancer detection gets new tests for early diagonosis...
Sep 18

LuminUltra submits COVID-19 clinical diagnostic testing kit for regulatory authorization in U.S., Canada

End-to-end solution and components offer flexibility to testing facilities, meeting high-volume demand and significantly boosting global testing capacity ...
Sep 16

FDA approves GSK and Innoviva's Trelegy Ellipta for the treatment of both asthma and COPD in the US

The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. ...
Sep 14

Junshi Biosciences receives FDA Breakthrough Therapy Designation for Toripalimab

Major breakthrough for treatment of Nasopharyngeal Carcinomar ...
Sep 11

20 Matching result(s) found!

-Advertisements-



Trending Now

Why Modern Lifestyle Causes Chronic InflammationAugust 05, 2026
Endometriosis Awareness: Understanding the Silent Condition Affecting Millions of Indian WomenAugust 05, 2026
A Complete Guide to Pregnancy Health Tips for Indian Women: Nutrition, Wellness, and What Every Expectant Mother Should KnowAugust 05, 2026
Why Preventive Healthcare for Children Is One of the Most Important Investments India Can MakeAugust 04, 2026
The Role of Pathology in Healthcare: From Diagnosis to Disease PreventionAugust 04, 2026
Pathophysiology of Psoriatic Arthritis: Clinical Presentation, Joint Damage Mitigation, and BiologicsAugust 04, 2026
Comprehensive Evaluation of Syncope: Cardiac vs. Neurological Origin WorkupsAugust 04, 2026
Common Medical Terms Explained: A Plain-Language Guide for Indian Patients and Healthcare SeekersAugust 03, 2026
Why Radiology Is the Backbone of Modern Medical Diagnosis and TreatmentAugust 03, 2026
Managing Urban Stress: Science-Backed Strategies for Mental Resilience in 2026 August 01, 2026
Managing Chronic Inflammation: The Role of Anti-Inflammatory Indian SuperfoodsAugust 01, 2026
Pathophysiology of Psoriatic Arthritis: Clinical Presentation, Joint Damage Mitigation, and BiologicsAugust 01, 2026
Early Markers of Glaucoma: Structural vs. Functional Ophthalmic Diagnostic ProtocolsAugust 01, 2026
Managing Complex Diabetic Foot Ulcers: Multidisciplinary Wound Care, Offloading, and RevascularizationAugust 01, 2026
The Future of Preventive Medicine: How India Is Moving From Cure to PreventionAugust 01, 2026
Why Young Indians Are Facing Heart Problems: Causes, Symptoms, and PreventionAugust 01, 2026
The Future of Preventive Screening: AI-Driven Early Cancer Detection in IndiaJuly 31, 2026
The Impact of Climate Change on Allergic Respiratory Diseases in Indian Cities July 31, 2026
Electronic Medical Records: What They Are, Why They Matter, and How India Is Embracing ThemJuly 31, 2026
Heatwave Health Risks in India: Symptoms, Treatment, and Prevention StrategiesJuly 31, 2026