US Food and Drug Administration Approves HAEGARDA® (C1 Esterase Inhibitor Subcutaneous [Human]) for Prevention of Hereditary Angioedema (HAE) Attacks in Pediatric Patients
AbbVie Receives Orphan Drug and Fast Track Designations from the US Food and Drug Administration for Elezanumab, an Investigational Monoclonal Antibody RGMa Inhibitor, for the Treatment of Spinal Cord Injury
US Food and Drug Administration (FDA) Accepts for Priority Review Bristol Myers Squibb and bluebird bio Application for Anti-BCMA CAR T Cell Therapy Idecabtagene Vicleucel (Ide-cel, bb2121)
Mallinckrodt Receives a Complete Response Letter from the US Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
Alphamab Oncology announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to KN046 for the treatment of thymic epithelial tumor
Ascendis Pharma A/S Announces US Food and Drug Administration (FDA) Accepts Biologics License Application (BLA) for TransCon™ hGH for Pediatric Growth Hormone Deficiency (GHD)
Kite Submits Supplemental Biologics License Application to US Food and Drug Administration for Yescarta® in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas | DNA RNA and Cells | News Channels
Liminal BioSciences Announces Resubmission of Biologics License Application to US Food and Drug Administration for Ryplazim® (plasminogen) for Treatment of Congenital Plasminogen Deficiency
Aerie Pharmaceuticals Announces U.S. Food and Drug Administration Approval of its Athlone, Ireland Facility for Production of Rhopressa® (netarsudil ophthalmic solution) 0.02%
Real Pet Food Company of Phoenix, AZ Voluntarily Recalls One Lot of Billy+Margot Wild Kangaroo and Superfoods Recipe Dog Food in 4 lb Bags Because of a Possible Salmonella Health Risk (USA)
U.S. Food and Drug Administration Approves Onureg® (azacitidine tablets), a New Oral Therapy, as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
Gilead's Investigational Antiviral Veklury® (Remdesivir) Receives US Food and Drug Administration Emergency Use Authorization for the Treatment of Patients With Moderate COVID-19 | Small Molecules | News Channels
Precision BioSciences Receives Fast Track Designation from U.S. Food and Drug Administration for PBCAR269A, an Investigational Allogeneic CAR T Therapy for Relapsed/Refractory Multiple Myeloma
Sun Pharmaceutical Industries, Inc. Issues Voluntary Nationwide Recall of RIOMET ER™ (Metformin Hydrochloride for Extended-Release Oral Suspension) Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit
ADC Therapeutics Submits Biologics License Application to the US Food and Drug Administration for Loncastuximab Tesirine for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
SHAREHOLDER ALERT: BioMarin Pharmaceutical, Inc. Sued for Violations of the Federal Securities Laws; Investors Who Lost Money Should Contact Block & Leviton LLP
Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
