T2 Biosystems Stock Tumbles: Company Lays Off 30% Of Workforce, Clocks 70% Decline In Q1 Revenues
T2 Biosystems Inc (NASDAQ: TTOO) has initiated a process to explore a range of strategic alternatives and a restructuring plan,
Why Integra LifeSciences Stock Is Tumbling
Integra LifeSciences Holdings Corp (NASDAQ: IART) shares are trading lower Tuesday after the company initiated a voluntary global recall.
Nasal-Spray Millionaire: Indivior’s Opvee Nasal Spray Gets FDA Green Light for Opioid Overdose Treatment
The FDA has approved Indivior PLC's (OTC: INVVY) Opvee (nalmefene) nasal spray for the emergency treatment of opioid overdose in adults and pediatric patients aged 12 years and older.
Unlocking a $750 Million Opportunity: Krystal Biotech’s Vyjuvek and its Potent Impact on Dystrophic Epidermolysis Bullosa Treatment
The FDA approved Krystal Biotech Inc's (NASDAQ: KRYS) Vyjuvek (beremagene geperpavec-svdt) for treating patients six months of age or older with
Filed On May 19, DiaMedica Therapeutics A Complete Clinical Hold Response With FDA For Clinical Hold On A Phase 2/3 Clinical Trial Of DM199; Response With FDA Requesting Clinical Hold Imposed On Phase 2/3 Clinical Trial Of DM199 For AIS Be Lifted
On May 22, 2023, DiaMedica Therapeutics Inc. (the "Company") announced that the Company filed on May 19, 2023 a complete clinical hold response with the U.S. Food and Drug Administration (the "FDA") requesting that the
What Now After FDA AdComm Rebuke for Intercept Pharmaceutical? Analyst Says Approval Of Intercept’s ‘OCA In NASH May Never Occur
On Friday, FDA's Gastrointestinal Drugs Advisory Committee voted 12 to 2—with two abstentions—that the benefits of Intercept Pharmaceutical Inc's ICPT Ocaliva 25 mg, also known as Obeticholic acid (OCA), don't outweigh the risks in nonalcoholic steatohepatitis (NASH)
Intercept Pharma Stock Tumbles: FDA Panel Votes Against Intercept’s Fatty Liver Drug, Dashing Its Dreams To Enter NASH Space
FDA's Gastrointestinal Drugs Advisory Committee voted 12 to 2—with two abstentions—that the benefits of Intercept Pharmaceutical Inc's (NASDAQ: ICPT) Ocaliva 25 mg, also known as Obeticholic acid (OCA), don't outweigh the risks in nonalcoholic steatohepatitis (NASH) patient
Processa Pharmaceuticals To Participate In A Panel On Interaction With he FDA At The World Orphan Drug Congress
Company also to provide a corporate overview in a separate session
HANOVER, MD, May 22, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) ("Processa" or the "Company"), a
FDA Approves First Redosable Gene Therapy, Krystal Biotech’s Treatment For Skin Blistering Disorder
The FDA approved Krystal Biotech Inc's (NASDAQ: KRYS) Vyjuvek (beremagene geperpavec-svdt) for the treatment of patients six months of age or older with dystrophic