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Pharma News
Pharma News
FDA Commissioner’s National Priority Vouchers Will Endanger Americans
WASHINGTON, D.C. – The Food and Drug Administration (FDA) has announced a program that will shorten review times assessing safety and efficacy for some new drugs to one to two months.
Hoth Therapeutics reports positive preclinical safety data for HT-KIT
NEW YORK - Hoth Therapeutics, Inc., a small-cap biotech company with a market capitalization of $17.17 million,
FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’
A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy Kalvista has been developing for hereditary angioedema.
Skye Bioscience to Present Expanded Preclinical
Skye Bioscience to Present Expanded Preclinical CB1 Antibody Data at the American Diabetes Association’s 85th Scientific Sessions
European pharma needs scalable models to succeed in US
HLTH Europe hosted discussions on the challenges European companies face while entering the US market.
FDA Grants Fast Track Designation to Nuvisertib in Myelofibrosis
The U.S. Food and Drug Administration (FDA) granted fast track designation to nuvisertib (TP-3654) for the treatment of patients with intermediate or high-risk myelofibrosis (MF...
Positive preclinical data supports potential of Neurizon’s NUZ-001 in Huntington’s disease
Neurizon Therapeutics, which is dedicated to advancing treatments for neurodegenerative diseases
ADC Therapeutics shutters UK R&D site
ADC Therapeutics shutters UK R&D site, culls several preclinical programs and trims workforce by 30%
AstraZeneca taps Chinese biotech in $5.2bn chronic disease research deal
AstraZeneca continues Western big pharma’s growing dependence on Chinese biotechs for drug discovery.
Sun Pharma's Halol plant gets 8 USFDA observations post inspection
Drug major Sun Pharma on Saturday said the US health regulator has issued a Form 483 with 8 observations after inspecting its Halol (Gujarat) manufacturing plant.
Texas governor signs bill allocating up to $100 million in funding for psychedelics research
Abbott's signing of Senate Bill 2308 comes as the governor faces political pressure from veterans groups to veto the state's proposed THC (Tetrahydrocannabinol) ban.
Fractyl Health to Present New Preclinical Data
Fractyl Health to Present New Preclinical Data from its Rejuva® Smart GLP-1™ Pancreatic Gene Therapy Platform
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