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Biotech

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Perrigo Seeks FDA Approval For the First OTC Contraceptive Pill

By Vandana Singh
July 11, 10:57 AM
Perrigo Company plc's (NYSE: PRGO) HRA Pharma has 

PRGO

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ViaCyte Acquisition Can Accelerate Vertex’s Ongoing Type 1 Diabetes Programs

By Vandana Singh
July 11, 10:54 AM
Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX) has agreed to acquire ViaCyte, a privately held biotechnology, for $320 million in cash. ViaCyte is focused…

VRTX

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Freeline Posts Cases Of Lower FIX Expression, Higher Liver Enzymes From Hemophilia Candidate

By Vandana Singh
July 11, 10:04 AM
Freeline Therapeutics Holdings plc (NASDAQ:FRLN) announced the presentation of safety and initial efficacy data from the first cohort of the Phase…

FRLN

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FDA Signs Off Nyxoah’s Genio Trial In Complete Concentric Collapse Patients

By Vandana Singh
July 11, 9:34 AM
The FDA has approved Nyxoah SA’s (NASDAQ:NYXH) Investigational Device Exemption (IDE) to initiate a trial, called ACCCESS, to evaluate the Genio…

NYXH

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  • FDA
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Co-Diagnostics Announces Shipment Of Monkeypox Virus Test

By Benzinga Newsdesk
July 11, 9:30 AM
Co-Diagnostics, Inc. (NASDAQ:CODX) (the "Company" or "Co-Dx"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that

CODX

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Why Are Pliant Therapeutics Shares Rallying Today?

By Vandana Singh
July 11, 8:18 AM
Pliant Therapeutics Inc’s (NASDAQ:PLRX) Phase 2a trial of PLN-74809 in patients with idiopathic pulmonary fibrosis (IPF) met its primary and…

PLRX

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Innoviva Bolsters Its Infectious Disease, Hospital Portfolio With La Jolla Deal

By Vandana Singh
July 11, 8:14 AM
Innoviva Inc (NASDAQ:INVA) has agreed to acquire La Jolla Pharmaceutical Company (NASDAQ:LJPC) for $5.95 per share, representing a premium of approximately 70%…

INVA

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  • Biotech
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Arcutis Biotherapeutics Announces Health Canada Accepts For Review New Drug Submission For Roflumilast Cream For Adults And Adolescents With Plaque Psoriasis

By Bill Haddad
July 11, 8:06 AM
Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as well as results from long-term safety studies If approved, roflumilast cream would be the first and

ARQT

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  • FDA
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T2 Biosystems Receives FDA Breakthrough Device Designation For T2Lyme Panel

By Benzinga Newsdesk
July 11, 8:02 AM
T2 Biosystems, Inc. (NASDAQ:TTOO) a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, announced today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device

TTOO

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FDA Clears LPCN 2101 IND For Adult Epilepsy Treatment

By Bill Haddad
July 11, 8:00 AM
 Lipocine Inc. (NASDAQ:LPCN), a biopharmaceutical company focused on developing innovative products to treat metabolic and central nervous system ("CNS") disorders with high unmet medical needs, announced

LPCN

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