FDA - Spark Newswire

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FDA
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Immutep Reports Will Evaluate Efti In Triple Combo Therapy Phase 1 Study With Chemotherapy, Anti-PD-1 Therapy

Today, 12:29 PM

New Phase I clinical trial, called INSIGHT-003, in patients with various solid tumours Expands the evaluation of efti into a triple combination therapy of efti, chemotherapy and anti-PD-1 therapy First patient in

IMMP

1 minute read

Tarsus Pharmaceuticals’ TP-03 Hits Primary, Secondary Endpoints In Demodex Blepharitis Study

By Vandana Singh

Today, 12:29 PM

Tarsus Pharmaceuticals Inc (NASDAQ:TARS) has reported topline data from Phase 2b/3 Saturn-1 trial evaluating TP-03 (lotilaner ophthalmic solution, 0.25%) in patients…

TARS

2 minute read

FDA
News

Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency

By Benzinga Newsdesk

Today, 12:29 PM

Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today announced that it has submitted a New Drug

AGIO

5 minute read

The Week Ahead In Biotech: Incyte, Ascendis FDA Decisions, Liver Congress Presentations And 4 IPOs

By Shanthi Rexaline

Today, 12:29 PM

Biotech stocks came under pressure in the week ended June 18, dragged by the negative sentiment that prevailed in the broader market due to macroeconomic worries.

ABBV

2 minute read

FDA
News

CytRx Comments On Orphazyme Complete Response Letter From FDA

By Benzinga Newsdesk

Today, 12:29 PM

CytRx Corporation (OTCQB:CYTR) ("CytRx"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, today noted that Orphazyme A/S

CYTR

1 minute read

FDA
News

Vertex Reports Health Canada Granted Marketing Authorization For TRIKAFTA In People 12+ With At Least 1 F508del Mutation

By Benzinga Newsdesk

Today, 12:29 PM

Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) today announced Health Canada has granted Marketing Authorization for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for the treatment of cystic fibrosis

VRTX

1 minute read

Europe Approves Sanofi’s Expanded Use Of Aubagio In Pediatric Patients With Multiple Sclerosis

By Vandana Singh

Today, 12:29 PM

The European Commission has approved Sanofi SA’s (NASDAQ:SNY) Aubagio (teriflunomide) for the treatment of pediatric patients 10 to 17 years of…

SNY

1 minute read

Hutchmed Files For Over $600M Hong Kong IPO

By Vandana Singh

Today, 12:29 PM

Hutchmed (China) Limited (NASDAQ:HCM) will look to raise $603 million as part of a Hong Kong IPO, listed in the…

HCM

1 minute read

Roche’s New COVID-19 Point Of Care Test Scores FDA Emergency Use Nod

By Vandana Singh

Today, 12:29 PM

The FDA has granted Emergency Use Authorization (EUA) to Roche Holding AG’s (OTC:RHHBY) Cobas SARS-CoV-2 Nucleic acid test for use on the…

RHHBF

1 minute read

Bristol Myers Onureg Scores European Approval As Maintenance Therapy For Acute Myeloid Leukemia

By Vandana Singh

Today, 12:29 PM

The European Commission has granted full marketing authorization to Bristol Myers Squibb & Co’s (NYSE:BMY) Onureg (azacitidine tablets) The approval comes as…

BMY