Fasenra: FDA Approves Under-the-Skin Shot to Help Reduce Flares in Hypereosinophilic Syndrome

Fasenra (benralizumab), a targeted medicine called a monoclonal antibody, binds to and reduces levels of eosinophils, a type of immune cell that can cause inflammation.This can ease symptoms in people with eosinophil-driven conditions.First approved in… Read more

Trimbow: A Triple-Combination Inhaler for Asthma Maintenance in Adults

Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate), a single inhaler that contains three medicines, is now FDA-approved for maintaining asthma control in adults. About 27 million Americans have asthma, of which 30% to 50% have frequent symptoms that… Read more

Datroway: FDA Approves Antibody-Drug Conjugate Injection for Advanced Triple-Negative Breast Cancer

Datroway (datopotamab deruxtecan-dlnk) is a prescription intravenous targeted cancer medicine called an antibody-drug conjugate (ADC).The FDA has approved it for adults with triple-negative breast cancer (TNBC) when the tumor cannot be removed with surgery (unresectable)… Read more

FDA Clears Once-Daily Linzess Capsule for Functional Constipation in Children Ages 2 Years and Older

Linzess (linaclotide) is a prescription once-daily oral medicine used to treat certain types of constipation, including those with no known cause and those related to irritable bowel syndrome (IBS-C). In the current approval, the FDA… Read more

Imfinzi: FDA Approves Immunotherapy Plus BCG Combination for High-Risk Early Non-Muscle-Invasive Bladder Cancer

Imfinzi (durvalumab) is a prescription immunotherapy medicine used to treat different types of cancer. The FDA has approved the combination of Imfinzi and Bacillus Calmette-Guérin (BCG) therapy to treat a high-risk, early form of bladder… Read more

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

Tecentriq and Tecentriq Hybreza: FDA Approves First ctDNA‑Guided Adjuvant Immunotherapies to Target Residual Muscle‑Invasive Bladder Cancer After Surgery

Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) are prescription immunotherapy medicines used to help the body’s immune system fight cancer. The FDA has now approved them to treat muscle-invasive bladder cancer (MIBC) in adults after… 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

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