63 h. 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.

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3 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 […]

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5 d. 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

1 week 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

1 week 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

3 w. ago Marius Pharmaceuticals and Hims & Hers™ Collaborate to Expand Access to KYZATREX® (testosterone undecanoate) CIII Capsules, the First FDA

RALEIGH, N.C., Sept. 10, 2025 (GLOBE NEWSWIRE) — Marius Pharmaceuticals, Inc. today announced a collaboration with Hims & Hers™, one of the largest digital health platforms for men, to make KYZATREX®, an FDA-approved oral testosterone replacement therapy for adult men with low or no testosterone levels due to certain medical conditions, available to patients through […]

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4 w. ago InnoCare Announces Approval of HIBRUKA (Orelabrutinib) for the Treatment of Marginal Zone Lymphoma in Singapore

BEIJING, Sept. 07, 2025 (GLOBE NEWSWIRE) — InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that HIBRUKA (orelabrutinib) has been approved by the Health Sciences Authority (HSA) of Singapore for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (R/R MZL). Dr. […]

Economics

last month U.S. FDA Approves Expanded Indication for VONVENDI® [von Willebrand factor (Recombinant)] for Adults and Children with Von Willebrand Disease

− Approval Expands Use of VONVENDI to Include Routine Prophylaxis to Reduce the Frequency of Bleeding Episodes in Adults with Type 1 and 2 Von Willebrand Disease (VWD) and On-Demand and Perioperative Management of Bleeding in Pediatric Patients with VWD1 − VONVENDI is the Only Recombinant Von Willebrand Factor Replacement Therapy with Approved Indications in […]

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