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Novartis receives FDA approval 177Lu-PSMA-617 for metastatic castration resistant prostate cancer

FDA breakthrough therapy for Novartis metastatic prostate cancer drug ...
Jun 21

Boehringer Ingelheim's Investigational Treatment for Schizophrenia receives FDA Breakthrough Therapy Designation

The company also announced the planned initiation of the innovative CONNEX Phase III clinical trial program assessing the safety and efficacy of BI 425809 ...
May 27

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

FDA Emergency Use Authorization Approval for ZEUS ELISA SARS-CoV-2 Total Antibody Test System

Now ELISA bases Covid test from Zeus Scientific...
May 19

US bans menthol and other flavored cigarettes

CDC bans all flavored cigarettes...
Apr 30

Sorrento receives FDA clearance Phase 2 study for Sti-3031 ; Advanced Urothelial Carcinoma

Sorrento intends to combine a variety of its proprietary mAbs in conjunction with the ADNAB technology platform...
Apr 28

FDA Approves GlaxoSmithKline's immunotherapy for Endometrial Cancer with specific biomarker

GSK gets FDA nod for Jemperli indicated for endometrial cancer...
Apr 26

Pharvaris Announces FDA Acceptance of IND Application for Prophylactic Treatment of HAE Using PHVS416

Pharvaris is a clinical-stage company focused on bringing oral bradykinin-B2-receptor antagonists to patients. ...
Apr 23

Exelixis ; U.S. FDA accepts investigational new drug application for XB002 in patients with Advanced Solid Tumors

New drug for treating advanced tumour under investigation...
Apr 07

GSK and Vir Biotechnology requests emergency use authorization to FDA for VIR-7831 for treatment of COVID-19

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE ...
Mar 27

GSK and Vir Biotechnology requests emergency use authorization to FDA for VIR-7831 for treatment of COVID-19

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE ...
Mar 27

FDA approves new indication for drug to treat Neurogenic Detrusor Overactivity in pediatric Patients

NDO is a dysfunction of the bladder that results from congenital conditions...
Mar 26

Precigen Receives FDA Orphan Drug Designation for PRGN-2012 Adenoverse

The drug is used for immunotherapy in patients with Recurrent Respiratory Papillomatosis (RRP)...
Mar 20

Cytocom receives FDA clearance of IND for Phase 2 clinical trial of CYTO-205 as treatment for COVID-19

Latest FDA News Update...
Mar 18

FDA warns against use of Ivermectin for prevention of Covid-19

Ivermectin is used for parasite control for horses in USA...
Mar 06

U.S. FDA expands approval of Pfizer’s LORBRENA as first-line treatment for ALK-Positive Metastatic Lung Cancer

In 2018, the FDA approved LORBRENA for the treatment of patients with ALK-positive metastatic NSCLC whose disease has progressed on crizotinib and at least ...
Mar 05

Johnson & Johnson's Covid-19 vaccine gets emergency use authorization from FDA

Johnson's vaccine is indicated for individuals above 18 years...
Mar 01

BeiGene reports FDA approval for Brukinsa(Zanubrutinib )

Brukisa is indicated for the treatment of adult patients with Waldenström’s Macroglobulinemia ...
Feb 19

Novartis receives FDA Breakthrough Therapy designations for STAMP inhibitor asciminib (ABL001)

Novartis receives FDA Breakthrough Therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukaemia ...
Feb 10

Moleculin Announces Annamycin Receives FDA Orphan Drug Designation for Soft Tissue Sarcomas

The FDA grants orphan drug designation to drugs and biologics that are intended for the treatment of rare diseases that affect fewer than 200,000 ...
Dec 30

US FDA accepts GSK’s filing of Nucala for use in chronic rhinosinusitis with nasal polyps

If approved, Nucala would be the only treatment approved in the US for use in four eosinophil-driven diseases. ...
Dec 08

Moleculin announces FDA approval of 3 Rare pediatric disease designations for WP1066

The designation entitles Moleculin to receive a transferrable Priority Review Voucher (PRV) upon New Drug Approval (NDA)...
Dec 03

Aprea Therapeutics receives FDA Fast Track Designation for Eprenetapopt in the treatment of Acute Myeloid Leukemia (AML)

Eprenetapopt indicated for the treatment of TP53 Mutant Acute Myeloid Leukemia (AML)...
Dec 02

RhoVac's Prostate Cancer Drug Candidate, RV001, is granted Fast Track Designation by the FDA

Latest FDA News Nov 26, 2020...
Nov 26

Impel Neuropharma reports FDA submission of new drug application For INP104

INP104 is indicated in treatment of acute migraine...
Nov 10

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