FDA Cites Eli Lilly for New Quality-control Problems at Drug Factory in New Jersey
-Reuters Citing FDA Document
Rigel Provides Update On Plans For Supplemental New Drug Application For Warm Autoimmune Hemolytic Anemia Program Following FDA Feedback
--Announces Workforce Reduction--
Despite Advancement, Benefits From Alzheimer’s Drugs May Be Limited, Say Researchers
Recently, Biogen Inc (NASDAQ:BIIB) and Eisai Co (OTC: ESALY) announced encouraging data from the most-watched Alzheimer’s therapies in the clinic. Lecanemab cleared accumulations…
Janssen Touts Encouraging Data From Two Ulcerative Colitis Treatments
Janssen Pharmaceutical, a unit of Johnson & Johnson (NYSE:JNJ), announced data from an ongoing analysis of a Phase 2a trial of guselkumab…
Centre Piece Of Merck’s $11.5B Acceleron Buyout Aces Late-Stage Cardiovascular Trial
Merck & Co Inc (NYSE:MRK) announced topline results from the pivotal Phase 3 STELLAR trial evaluating the safety and…
Iradimed Withdraws FDA Application For Updated MR IV Pump System
Iradimed Corporation (NASDAQ:IRMD) voluntarily withdrew its 510(K) application for its next-generation MRidium 3870 Infusion Pump System. Roger Susi, President and Chief…
Why Applied DNA Sciences Stock Is Soaring Today
Applied DNA Sciences Inc (NASDAQ: APDN) shares are soaring Monday after the company announced it received its largest single purchase order for LinearDNA to date.
FDA Rejects Supernus Pharma’s Minimally Invasive Parkinson’s Therapy
Supernus Pharmaceuticals Inc (NASDAQ:SUPN) received FDA’s complete response letter (CRL) for the SPN-830 marketing application. SPN-830 is an investigational apomorphine infusion…
FDA Approves scPharmaceuticals’ Self-Administered Med For Congestion in Chronic Heart Failure
The FDA has approved scPharmaceuticals Inc’s (NASDAQ:SCPH) Furoscix (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for…
Novavax and SK bioscience File Post Approval Change Application In South Korea For Nuvaxovid COVID-19 Vaccine As A Booster In Adults Aged 18 And Older
https://ir.novavax.com/Switzerlands-Federal-Office-of-Public-Health-Recommends-Novavax-Nuvaxovid-TM-COVID-19-Vaccine-as-a-Booster-in-Adults-Aged-18-and-Older