FDA Expands Tremfya Label to Highlight Protection Against Joint Damage in Psoriatic Arthritis

Tremfya is a prescription biologic medicine used as an intravenous injection or under-the-skin shot for treating certain immune-related inflammatory diseases. The FDA has approved an update to its label to include evidence that Tremfya can… Read more

Afrezza: FDA Clears Use for Children 6 and Older With Type 1 or Type 2 Diabetes

Afrezza is a fast-acting insulin that you breathe in as you start a meal. It lowers blood sugar by helping your muscles and fat use sugar and by telling your liver to make less sugar.… Read more

Beqalzi: FDA Approves New Oral BCL-2 Blocker for Relapsed or Refractory Mantle Cell Lymphoma

Beqalzi (sonrotoclax) is a prescription, targeted, oral cancer medicine that has received accelerated FDA approval for treating adults with mantle cell lymphoma (MCL) that has relapsed or become resistant after at least two prior treatments,… Read more

Inqovi: FDA Approves First All‑Oral Regimen for Certain Patients With Newly Diagnosed Acute Myeloid Leukemia

Inqovi is a fixed‑dose oral pill that contains two medicines, decitabine and cedazuridine.The FDA has approved using Inqovi along with another oral pill, venetoclax, for treating newly diagnosed acute myeloid leukemia (AML) in adults who… Read more

Enhertu: FDA Clears New Pre- and Post-Surgery Uses in HER2-Positive Early Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is a prescription intravenous (IV) targeted cancer treatment called an antibody-drug conjugate. The FDA has approved it for two uses in adults with HER2-positive early-stage breast cancer. It can now be used… Read more

Opzelura: FDA Expands Use of Steroid-Free Skin Cream for Young Children With Eczema

Opzelura (ruxolitinib) is a prescription cream that helps reduce skin inflammation.It works by blocking certain proteins in the body called Janus kinases (JAKs) that help regulate the immune system and can cause skin inflammation when… Read more

FDA Approves At-Home Once-Weekly Leqembi Injection as Maintenance Therapy for Early Alzheimer’s Disease

Leqembi (lecanemab-irmb) is a prescription medicine approved to treat early stages of Alzheimer’s disease, such as mild cognitive impairment or mild dementia.The recent FDA approval of Leqembi IQLIK (pronounced “I Click”) introduces a once-weekly, under-the-skin… Read more

FDA Expands Repatha Approval

Repatha (evolocumab) is an injectable medicine that helps lower levels of low-density lipoprotein cholesterol (LDL), often called “bad” cholesterol.Approved in 2015, Repatha can now be used in adults with poorly controlled LDL who haven’t been diagnosed… Read more

Wayrilz: A New Twice-Daily Pill for Persistent and Chronic Immune Thrombocytopenia

Wayrilz (rilzabrutinib) is a new oral medicine for adults with persistent (lasting 3-12 months) or chronic (lasting more than 12 months) immune thrombocytopenia (ITP) who haven’t had success with a prior treatment.ITP is a disease… Read more

FDA Approves Ziftomenib: First Once-Daily Oral Therapy for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

Ziftomenib, sold under the brand name Komzifti, is a new oral medicine approved to treat adults with a type of blood cancer called acute myeloid leukemia (AML).It’s meant for people whose AML has come back… Read more