14 h. ago FDA Approves Expanded Indication for UZEDY® (risperidone) Extended

FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.1 UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults.1 This […]

Other

46 h. ago U.S. FDA approves Boehringer’s JASCAYD® (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade

Ingelheim, Germany/Ridgefield, Connecticut, U.S. Idiopathic pulmonary fibrosis (IPF) is a progressive disease, causing a continuous decline in lung function.1 Approval is based on results from two clinical trials, which showed reduction in Forced Vital Capacity decline with JASCAYD versus placebo in adults with idiopathic pulmonary fibrosis (IPF).2,3 Nerandomilast is a new treatment option for adult […]

Economics

4 d. ago Eisai and Biogen Announce U.S. Availability of LEQEMBI® IQLIK™ (lecanemab

New LEQEMBI Companion™ program launched to expand helpful resources for patients throughout the treatment journey, including Nurse Educators who can provide patients with injection training, and an injection tracking tool and more LEQEMBI IQLIK, approved by the U.S. FDA in August 2025, is the first and only anti-amyloid treatment to offer an at-home injection after initial […]

Other

7 d. ago FDA approves another abortion pill, sparks conservative backlash

The FDA approved the original version of mifepristone in 2000 and gradually eased access over time.

Other

8 d. ago FDA approves another generic abortion pill, prompting outrage from conservatives

WASHINGTON (AP) — Federal officials have approved another generic version of the abortion pill mifepristone, a regulatory formality that quickly triggered pushback from anti-abortion groups aligned with the Trump administration. Drugmaker Evita Solutions announced on its website that the Food and Drug Administration signed off on its low-cost form of the pill, which is approved […]

Other

1 week ago enGene Appoints Hussein Sweiti, M.D., MSc, as Chief Medical Officer

Bladder cancer development leader who helped drive recent FDA product approval in NMIBC joins to lead research and development strategy Appointment strengthens enGene’s clinical development and regulatory capabilities ahead of planned 2H 2026 BLA submission for detalimogene BOSTON & MONTREAL — enGene Holdings Inc. (Nasdaq: ENGN, “enGene” or the “Company”), a clinical-stage, non-viral genetic medicine […]

Events

2 w. ago Crinetics Announces FDA Approval of PALSONIFY™ (paltusotine) for the Treatment of Adults with Acromegaly

Novel nonpeptide SST2 agonist PALSONIFY advances the treatment paradigm as the first once-daily, oral therapy approved by the FDA to treat acromegaly Approval based on data from two pivotal Phase 3 trials where PALSONIFY was well tolerated and resulted in rapid, durable, and consistent biochemical control and reduced symptom burden Launch of lead product PALSONIFY […]

Economics

2 w. ago Sapu Nano’s Sapu003 Advances to Human Clinical Testing – Transforming Everolimus Delivery with Full Bioavailability for Breast Cancer Patients

Sapu003 Designed to Overcome Limitations of Afinitor®, FDA-Approved Oral Everolimus, by Delivering Full Strength of the Drug via Intravenous Injection SAN DIEGO, Sept. 24, 2025 (GLOBE NEWSWIRE) — via IBN — Sapu Nano, developer of Deciparticle™, today announced that it has received approval from Australia’s Human Research Ethics Committee (HREC) to begin enrolling patients in […]

Science

2 w. ago Ship Docks at Sanctioned Russian LNG Plant’s New Production Line

A liquefied natural gas tanker docked at a new production line at a US-sanctioned Russian facility in the Arctic, indicating that Moscow is pressing ahead with expanding energy exports despite western restrictions.

Events