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Oyster Point Pharma Announces FDA Approval of TYRVAYA (varenicline solution)

Nasal spray for the treatment of the signs and symptoms of Dry Eye Disease...
Oct 20

ImmixBio announces FDA Orphan drug designation for IMX-110 for the treatment of Soft Tissue Sarcoma

Latest pharma news update...
Oct 04

U.S. FDA approves LIVMARLI (maralixibat) as the First and Only Approved Medication for the Treatment of Cholestatic Pruritus

Indicated for patients with Alagille Syndrome one year of age and older...
Oct 04

FDA approves Abbott's Amplatzer Talisman System for PFO Closure in people at risk of recurrent Stroke

Latest Pharma News update...
Oct 04

Axsome Therapeutics announces FDA acceptance of New Drug Application for AXS-07

AXS-07 is indicated for the acute treatment of Migraine...
Sep 16

Versantis Receives U.S. FDA Orphan Drug Designation for VS-01

Latest pharma news updates...
Sep 13

Investigation finds nearly half of drugs granted FDA ‘fast track’ approval lack proven clinical benefit

Process plagued by missing efficacy data and questionable evidence with standards of evidence being too low ...
Aug 02

FDA Clearance of IND for FPI-1966, Radiopharmaceutical for Head and Neck and Bladder Cancers Expressing FGFR3

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966 ...
Jul 30

FDA Clearance of IND for FPI-1966, Radiopharmaceutical for Head and Neck and Bladder Cancers Expressing FGFR3

Fusion Pharmaceuticals Announces FDA Clearance of IND for FPI-1966 ...
Jul 30

FDA Grants Alkeus Pharmaceuticals Breakthrough Therapy Designation for ALK-00 ; Stargardt Disease

Latest FDA news update...
Jul 16

Sanofi extends collaboration with Genedata for Pharmaceutical Development & Manufacturing Science

Latest FDA approvals update...
Jul 16

U.S. FDA approves finerenone for the treatment of patients with chronic kidney disease associated with type 2 diabetes

Finerenone has also been submitted for marketing authorization in the European Union (EU) and in China...
Jul 12

Immutep receives FDA and IRB approval in the US for Phase IIb TACTI-003 trial in HNSCC

Immutep was granted Fast Track designation for efti to treat 1st line HNSCC patients by the US FDA in early April 2021. ...
Jul 12

FDA issues Actemra drug for COVID under Emergency Use Authorization (EUA)

The drug, Actemra (tocilizumab) has shown efficacy in treating COVID patients with better results by reducing the death and mortality rate along with complications. FDA ...
Jun 25

Bioheng Biotech received Orphan Drug Designation from the U.S. FDA for the treatment of T-ALL.

New approval for treating leukomia...
Jun 22

Roche SARS-CoV-2 molecular test granted first FDA Emergency Use Authorization for PCR testing for Coronavirus

Roche SARS-CoV-2 molecular test for PCR testing is effective for both symptomatic and asymptomatic Covid individuals ...
Jun 22

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

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

FDA grants accelerated approval for Alzheimer’s Disease

FDA shows hope to Alzheimer’s Disease patients this year. The drug Aduhelm may provide a sigh of relief to the patients suffering from Alzheimer’...
Jun 09

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 Approves GlaxoSmithKline's immunotherapy for Endometrial Cancer with specific biomarker

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

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

BioXcel Therapeutics receives FDA Breakthrough Therapy Designation for BXCL501 for the acute treatment of Dementia

Latest FDA approvals update...
Mar 16

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