FDA Approvals News
Latest fda approvals news, reviewed by pharmacists.
FDA Approvals articles
FDA ApprovalsDevice to Reduce Chemo Hair Loss Cleared for Marketing
Dignitana DigniCap Cooling System, to reduce hair loss in breast cancer patients, approved for marketing by FDA
FDA ApprovalsNew Rx Treats Most Common Inherited Bleeding Disorder
Vonvendi, von Willebrand factor (Recombinant), FDA-approved to treat von Willebrand disease
FDA ApprovalsFDA Approves New von Willebrand Rx
Vonvendi, von Willebrand factor (Recombinant), approved to treat von Willebrand disease
FDA ApprovalsChewable ADHD Rx Approved
QuilliChew ER (methylphenidate hydrochloride), from Pfizer, approved to treat ADHD
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FDA ApprovalsRare Enzyme Disorder Rx Approved
Kanuma (sebelipase alfa) approved to treat lysosomal acid lipase deficiency by FDA
FDA ApprovalsBendeka Gets the Green Light
Bendeka (bendamustine hydrochloride) injection approved to treat chronic lymphocytic leukemia, indolent B-cell non-Hodgkin lymphoma
FDA ApprovalsA Big Month for Multiple Myeloma
Darzalex, Ninlaro and Empliciti approved to treat multiple myeloma in November
FDA ApprovalsA New Multiple Myeloma Treatment
Empliciti (elotuzumab) FDA-approved to treat multiple myeloma patients who have received prior medications
FDA ApprovalsFDA Approves New Multiple Myeloma Rx
Empliciti (elotuzumab) approved to treat multiple myeloma patients who have received prior medications
FDA ApprovalsFirst Flu Vaccine with Adjuvant Approved
Fluad, first seasonal influenza vaccine containing adjuvant, approved by FDA
FDA ApprovalsNew Indication for Pradaxa
Pradaxa (dabigatran etexilate mesylate) approved for prophylaxis of deep venous thrombosis and pulmonary embolism after hip replacement surgery
FDA ApprovalsFDA OKs Lung Cancer Rx Portrazza
Portrazza (necitumumab), from Eli Lilly, approved to treat advanced squamous non-small cell lung cancer
FDA ApprovalsAnthrax Vaccine Gets FDA Nod
BioThrax (Anthrax Vaccine Adsorbed) approved to prevent disease following exposure to Bacillus anthracis
FDA ApprovalsOpdivo Approved to Treat Kidney Cancer
Opdivo (nivolumab) approved to treat advanced renal cell carcinoma
FDA ApprovalsNew Multiple Myeloma Rx Gets Go-Ahead
Ninlaro (ixazomib), from Takeda, FDA-approved to treat multiple myeloma
FDA ApprovalsNinlaro Approved for Multiple Myeloma
Ninlaro (ixazomib), from Takeda, approved to treat multiple myeloma
FDA ApprovalsFirst Anti-Overdose Nasal Spray Gets Green Light
Narcan nasal spray (naloxone hydrochloride) FDA-approved to treat opioid overdose
FDA ApprovalsOverdose Nasal Spray Rx Approved
Narcan nasal spray (naloxone hydrochloride) approved to reverse opioid overdose
FDA ApprovalsA Shot Against Multiple Myeloma
Darzalex (daratumumab), from Janssen, FDA-approved to treat multiple myeloma
FDA ApprovalsNew Rx for Multiple Myeloma
Darzalex (daratumumab), from Janssen, approved to treat multiple myeloma
FDA ApprovalsModified Hemophilia Rx Approved
Adynovate, Antihemophilic Factor (Recombinant), PEGylated approved for use in hemophilia A patients
FDA ApprovalsFDA Approves New Lung Cancer Rx
Osimertinib (Tagrisso), from AstraZeneca, approved to treat mutation-positive non-small cell lung cancer
FDA ApprovalsA New Rx Combo for Melanoma
Cotellic (cobimetinib), from Genentech, approved for use with vemurafenib to treat advanced melanoma
FDA ApprovalsMelanoma Rx Approved as Part of Combo
Cotellic (cobimetinib) approved for use with vemurafenib to treat advanced melanoma