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SHARx Focuses on Rx Continuity for Employers and Patients as Customs Requirements Change

Changes to customs procedures could affect some pathways used by Americans to obtain lower-cost prescription medications. The industry experts at SHARx, a supply-chain and procurement management company, are advocating to ensure those in need of...

Lundbeck Receives Marketing Authorization for Vyepti® (eptinezumab) in Japan for the Prevention of Migraine Attacks

H. Lundbeck A/S announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has granted marketing authorization for eptinezumab for the prevention of migraine attacks in adults, marking an important milestone for patients in Japan...

Avenacy Launched Cyclophosphamide for Injection, USP in the U.S. Market

Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, announced it has launched Cyclophosphamide for Injection, USP in the United States as a therapeutic generic equivalent for Cytoxan® as approved by...

FDA Clears Roche's cobas® BV/CV Assay, Enabling Fast and Highly Accurate Diagnosis of Vaginitis

Roche announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its cobas® BV/CV (Bacterial vaginosis/Candida vaginitis) assay. This molecular diagnostic test provides results for both Bacterial vaginosis (BV) and...

Children's Hospital of Philadelphia Initiative Substantially Increases Naloxone Co-Prescribing When Prescribing Outpatient Opioids

A multidisciplinary team at Children's Hospital of Philadelphia (CHOP) substantially increased naloxone co-prescribing for patients prescribed outpatient opioid prescriptions through an enterprise-wide quality improvement initiative designed to...

BioMarin's Supplemental New Drug Application for Full Approval of VOXZOGO® (vosoritide) for Children With Achondroplasia Accepted by the U.S. Food and Drug Administration

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental New Drug Application (sNDA) for VOXZOGO® (vosoritide) for full approval in children with achondroplasia. . "This...

FDA Approves Expanded Indication for Octapharma USA's wilate® for Prophylaxis of von Willebrand Disease in Children Younger Than 6 Years

On July 2, 2026, the U.S. Food and Drug Administration (FDA) approved the use of wilate® (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) for routine prophylaxis to reduce the frequency of bleeding episodes in pediatric patients...

Eligible Medicare Beneficiaries Living with Obesity Can Now Access Wegovy® Through the Medicare GLP-1 Bridge

Starting today FDA-approved Wegovy® (semaglutide) is available through the Medicare GLP-1 Bridge, a new access pathway for millions of older adults living with obesity. Obesity is a serious, common chronic disease among older Americans and Wegovy®...

Upsher-Smith Expands KYMBEE™ (Deflazacort) Family of Products with Launch of Oral Suspension for the Treatment of Duchenne Muscular Dystrophy

Upsher-Smith Laboratories, LLC (Upsher-Smith), a subsidiary of Bora Pharmaceuticals Co., Ltd. (6472.TW and BORAY.OTCQX) today announced the launch of KYMBEE™ (deflazacort) Oral Suspension, 22.75 mg/mL indicated for the treatment of Duchenne...

EVERY and Huvepharma Announce Fourfold Expansion of Production Capacity

The EVERY Company ("EVERY"), a leader in highly functional egg proteins produced via precision fermentation, announced a significant manufacturing expansion with its strategic partner, Huvepharma, a global pharmaceutical company with a focus on...

XOCOVA® Becomes First Oral Option for Post-Exposure COVID-19 Prevention

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved XOCOVA® (ensitrelvir), an oral antiviral, for...

Lundbeck Receives Marketing Authorization in South Korea for Vyepti® (eptinezumab) for the Preventive Treatment of Migraine

H. Lundbeck A/S (Lundbeck) announced that the Ministry of Food and Drug Safety (MFDS) of South Korea has granted marketing authorization for eptinezumab for use in adults with migraine. Migraine is a progressive and debilitating neurological...

Viralgen Teams with Elaaj Bio to Advance CDKL5 Deficiency Gene Therapy

Viralgen, a leading contract development and manufacturing organization (CDMO) specializing in recombinant adeno-associated virus (rAAV) gene therapies, announced today a partnership with Elaaj Bio, a biotechnology company focused on development...

Amazon Pharmacy Expands Same-Day Delivery and Kiosk Access for New Ozempic® Pill

Amazon Pharmacy a full-service digital pharmacy that delivers medications directly to customers' homes, is expanding access to Novo Nordisk's Ozempic® pill, the only FDA-approved oral GLP-1 medication to treat type 2 diabetes. Amazon Pharmacy will...

Pharmacists gain a flexible, space-saving option as YARAL Pharma launches its 15-count Diclofenac Epolamine Topical System 1.3%

YARAL Pharma Inc. the rapidly growing U.S. generics subsidiary of IBSA (Institut Biochimique SA), announced that its Diclofenac Epolamine Topical System 1.3%, the authorized generic of Flector® (diclofenac epolamine) topical system 1.3%, is now...

Lasix® ONYU® Receives CE Marking, Advancing Toward International Authorization; EMA Approves for Centralized Review Based on Innovation

SQ Innovation, developer of Lasix® ONYU, announced two important regulatory milestones in its international expansion strategy: the receipt of a CE marking certificate for the Lasix ONYU device, and the acceptance of Lasix ONYU by the European...

Constance Sabbagh Appointed as General Manager as Avanzanite Expands French Operations

Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today announced its expansion into France, Europe’s second largest economy, and the appointment of Constance Sabbagh...

FDA Grants KORU Medical Systems 510(k) Clearance for RYSTIGGO® Delivery via FreedomEDGE® Infusion System

KORU Medical Systems, Inc. a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and patient-centric large volume subcutaneous infusion solutions, announced that the Company received...

RoslinCT and BOOST Pharma Form Strategic Manufacturing Partnership to Advance Cell Therapy for Osteogenesis Imperfecta

RoslinCT, a global contract development and manufacturing organization (CDMO) specializing in advanced cell therapies, and BOOST Pharma, a clinical-stage biotechnology company developing first-in-class cell therapies for rare paediatric skeletal...

Jazz Pharmaceuticals presents new clinical and translational data for Modeyso™ (dordaviprone) in H3 K27M-mutant diffuse midline glioma at SNO 2025

Jazz Pharmaceuticals plc announced that the company will present five abstracts at the 2025 Society for Neuro-Oncology (SNO) Annual Meeting taking place November 19-23 in Honolulu, Hawaii. The presentations will feature both clinical and...

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