Rigel Provides Update On Plans For Supplemental New Drug Application For Warm Autoimmune Hemolytic Anemia Program Following FDA Feedback
--Announces Workforce Reduction--
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…
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
Daré Bioscience Announces IDE Approval For A Single Arm, Open-Label Pivotal Contraceptive Efficacy Study Of Ovaprene, An Investigational Hormone-Free Monthly Intravaginal Contraceptive
Daré Bioscience, Inc. (NASDAQ:DARE), a leader in women’s health innovation, today announced that the U.S. Food & Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application
scPharmaceuticals Announces FDA Approval Of FUROSCIX
BURLINGTON, Mass., Oct. 10, 2022 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of
IRADIMED CORPORATION Withdraws 510(k) With Plans To Resubmit After Further Discussions With FDA
IRADIMED CORPORATION (the "Company") (NASDAQ:IRMD) today announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump.
Roger Susi,
Immatics Reports Interim Clinical Data Update On ACTengine IMA203 TCR-T Monotherapy Targeting PRAME
Clinical validation of PRAME as multi-tumor target with large potential for TCR-based therapies: confirmed responses in different solid cancers, in patients with high and low PRAME expression
Update covers data from
Iovance Biotherapeutics Announces First Patient Dosed With PD-1 Inactivated Tumor Infiltrating Lymphocyte (TIL) Therapy
Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, announced that the first patient was dosed, and completed the safety observation