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You searched for : FdaApproval

	Breaking the Monopoly: Gland Pharma’s FDA-Cleared Injections Signal a New Era for Critical Care FDA-approved injectables adds credibility in Africa, Latin America, and beyond. The ripple effect may elevate Indian pharmaceutical manufacturing from “copycat” to “crown-standard.”... Aug 16
	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
	FDA approves Abbott's Amplatzer Talisman System for PFO Closure in people at risk of recurrent Stroke 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
	ImmixBio announces FDA Orphan drug designation for IMX-110 for the treatment of Soft Tissue Sarcoma 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
	Sanofi extends collaboration with Genedata for Pharmaceutical Development & Manufacturing Science Latest FDA approvals update... Jul 16
	FDA Grants Alkeus Pharmaceuticals Breakthrough Therapy Designation for ALK-00 ; Stargardt Disease Latest FDA news update... Jul 16
	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
	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
	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
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Search Results

Breaking the Monopoly: Gland Pharma’s FDA-Cleared Injections Signal a New Era for Critical Care

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

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

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

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

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

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

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

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

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

Sanofi extends collaboration with Genedata for Pharmaceutical Development & Manufacturing Science

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

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

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

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

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

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

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

FDA grants accelerated approval for Alzheimer’s Disease

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

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

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

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

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

Precigen Receives FDA Orphan Drug Designation for PRGN-2012 Adenoverse

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