April 10, 2026 - Apotex Corp. today announced it has received the first U.S. Food and Drug Administration (FDA) Tentative Approval for its Abbreviated New Drug Application (ANDA) for Semaglutide Injection, marking a significant milestone in expanding affordable access to complex peptide therapies for patients across the United States. This approval reinforces Apotex's leadership in bringing high value, technically challenging medicines that help improve patient access and support a more sustain

16-Week Study Evaluates One-Step Dose Titration to 48 mg and Two-Step Dose Titration to 64 mg in Obese Otherwise Healthy Adults April 10, 2026 --MetaVia Inc. (Nasdaq: MTVA), a clinical-stage biotechnology company focused on transforming cardiometabolic diseases, today announced that the first patient has been dosed in Part 3 of its Phase 1 clinical trial evaluating DA-1726, a novel dual oxyntomodulin (OXM) analog targeting both GLP-1 (GLP1R) and glucagon (GCGR) receptors. Part 3 of the Phase 1

April 10, 2026 -- Lynk Pharmaceuticals Co., Ltd. ("Lynk Pharmaceuticals"), a clinical-stage innovative drug development company focused on therapies for immune and inflammatory diseases, today announced that the New Drug Application (NDA) for its core product, zemprocitinib capsules, for the treatment of moderate-to-severe atopic dermatitis (AD), has been formally accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA). This acceptance marks

The company has enrolled 10 patients, marking early momentum in evaluating a novel, non-invasive, drug-centered therapeutic approach to brain cancer treatment. April 9, 2026 -- Alpheus Medical, Inc., a private, clinical-stage biotechnology company, today announced the initiation of its Phase 2b randomized controlled trial in newly diagnosed glioblastoma (nGBM) with 10 patients enrolled to date and additional clinical sites continuing to come online. Glioblastoma is a highly infiltrative brain

GSK discontinued Wellcovorin in 1999, but the FDA in September last year asked the pharma to re application, pointing to its potential to treat cerebral folate deficiency with “autistic features.” GSK has withdrawn an approval application for Wellcovorin, a decades-old drug that late last year gained renewed attention after the members of the Trump administration publicly suggested it has the potential to treat autism symptoms. The pharma requested to terminate the new drug application because

Partnering with Parent Project Muscular Dystrophy to ensure timely access to the trial for eligible patients ~15,000 children are living with DMD in the U.S. April 07, 2026 -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the United States Food and Drug Administration (FDA) has granted Investigational New Drug (IND) clearance to directly proceed for a registrational clinical trial evaluating Ryoncil® (rem

First-in-class TET2 activator targets DNA damage response in GBM and other cancers Strong preclinical efficacy, brain penetration, and safety pro clinical advancement Study led by world-leading glioblastoma investigators, including Dr. Roger Stupp Hemispherian AS, a clinical-stage oncology company developing novel small molecule therapeutics, today announced the initiation of a first-in-human Phase 1/2a clinical trial of GLIX1 in patients with recurrent and progressive glioblastoma (GBM) and ot

April 7, 2026 -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today the initiation of the dose expansion phase in their clinical study evaluating spevatamig in combination with chemotherapy for the treatment of biliary tract cancer (BTC), following dose-limiting toxicity (DLT) clearance at two dose levels. Spevatamig is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin

April 7, 2026 -- Global pharmaceutical leader Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Dapagliflozin Tablets, 5 mg and 10 mg. The U.S. FDA has approved Lupin's Dapagliflozin Tablets, 5 mg and 10 mg, as bioequivalent to Farxiga® for the indications in the approved labeling. Lupin Limited is a globa

By reducing dissociation and sedation risk, ALA-3000 may eliminate the ≥2-hour post-dose monitoring requirement, reducing clinic operating costs, improving patient throughput, and supporting a more cost-effective and reimbursement-aligned treatment model. April 6, 2026 -- Alar Pharmaceuticals Inc. (Alar, TPEx:6785), a clinical-stage biopharmaceutical company focused on developing long-acting injectables (LAIs), today announced the positive results from its phase 1 clinical study of ALA-3000, a