Press Releases

PL Developments (PLD), a leader in the development, manufacturing, packaging, and distribution of consumer healthcare products, today announced two significant milestones: FDA approval for its Omeprazole OTC ANDA and the successful refinancing of its corporate debt. FDA Approval for Omeprazole OTC The FDA has granted approval for PLD's Omeprazole Magnesium Tablet, a product comparable to Prilosec® OTC. The product will be manufactured at PLD's

AstraZeneca’s Fasenra (benralizumab) has been approved in the European Union (EU) as an add-on treatment for adult patients with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). EGPA is a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal.1,2 The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on posit

The life science group Sartorius is launching Sartobind® Rapid A Lab, the latest innovation in our portfolio of laboratory separation technologies. Featuring the fastest Protein A matrix on the market, this groundbreaking affinity chromatography unit is set to deliver unparalleled productivity and transform antibody purification processes. Sartobind® Rapid A Lab brings the next generation of chromatography membranes to research scientists. Each plug-and-play unit is ready fo

Regeneron Pharmaceuticals, Inc. and Sanofi will present positive data from the Phase 3 LIBERTY-CUPID Study C evaluating the investigational use of Dupixent® (dupilumab) in biologic-naïve patients with uncontrolled chronic spontaneous urticaria (CSU) who receive background therapy with antihistamines. Results showed treatment with Dupixent significantly reduced itch and urticaria activity (itch and hive) scores from baseline, and a higher proportion of patients achieved well-cont

Novartis today presented 12-month data from the Phase III APPEAR-C3G study at American Society of Nephrology (ASN) Kidney Week 2024 showing that patients with C3 glomerulopathy (C3G) treated with oral Fabhalta® (iptacopan) in addition to supportive care experienced clinically meaningful, sustained results at one year.1 These data confirm treatment with Fabhalta resulted in clinically meaningful proteinuria reduction, which was seen as early as 14 days, and sustained at 12 months

Lyell Immunopharma, Inc. announced today that it has entered into a definitive agreement to acquire ImmPACT Bio USA Inc. (“ImmPACT”), a privately-owned clinical-stage biotechnology company. ImmPACT’s lead program, IMPT-314, is a CD19/20-targeting chimeric antigen receptor (CAR) T-cell product candidate that Lyell will continue to develop for hematologic malignancies, including large B-cell lymphoma. IMPT-314 was designed to outperform the efficacy of approved CD19 CAR T-cell

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for breast cancer were updated to recommend ribociclib (Kisqali®) as a Category 1 preferred CDK4/6 inhibitor (CDK4/6i) adjuvant therapy for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC) in combination with an aromatase inhibitor (AI)1. Ribociclib (Kisqali) is the only CDK4/6i recommended for both all node-positive disease as well as for

Tolmar, Inc. a fully integrated pharmaceutical company, announced today the launch of a telemedicine consultation program for JATENZO® (testosterone undecanoate). This program was enabled by Tolmar's engagement of UpScriptHealth, a direct-to-patient telehealth company providing new distribution channels for pharmaceutical and medical device brands. Through their collaboration, UpScriptHealth will provide telehealth consultations for JATENZO, an oral testosterone replacement therapy (T

Merck known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older. The updated ACIP guidelines recommend a single dose of

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO ® (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. ABRYSVO now offers the broadest RSV vaccine indication for adults, which previously included those 60 years and older.