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Eisai submitted a rolling sBLA to the U.S. FDA for LEQEMBI® IQLIK™ as a subcutaneous starting dose to treat early Alzheimer’s, under Fast Track status

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...

CorrectSequence Therapeutics' CS-101 Achieves Promising Results in First Patient: High-Precision Base Editing Clinical Treatment for Sickle Cell Disease

CorrectSequence Therapeutics Co., Ltd. (Correctseq), a clinical-stage biotechnology company pioneering transformer Base Editing (tBE) technology for the treatment of severe diseases, today announced the successful treatment of the first sickle...

Theravance Biopharma completes enrollment in Phase 3 CYPRESS study of Ampreloxetine for neurogenic orthostatic hypotension

Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...

In Afghanistan, WHO and UNICEF will launch a polio vaccination campaign utilizing the PharmaJet® Tropis® ID delivery system

PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, announced that the WHO prequalified Tropis ID delivery system will be used to support a polio eradication...

Proving the strength of its drug-delivery platform, the Daewoong Therapeutics Microneedle Patch achieves best-in-class bioavailability

Daewoong Pharmaceutical (Co-CEOs Seong-Soo Park and Chang-Jae Lee) and Daewoong Therapeutics (CEO Bok-Ki Kang) announced that their proprietary semaglutide microneedle patch achieved more than 80%relative bioavailability compared to the injectable...

Jazz Pharmaceuticals announces the U.S. FDA approval of Modeyso™ (dordaviprone) as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...

Roche's first respiratory test, powered by TAGS technology, has received FDA clearance for SARS-CoV-2, Influenza A, Influenza B, and RSV

Roche announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for the cobas® Respiratory 4-flex. This is the first FDA-cleared assay utilizing Roche's innovative TAGS (Temperature-Activated Generation of Signal) technology, designed...

MediPharm Labs launches a new nighttime inhaler, expanding its leading CBN oil portfolio

MediPharm Labs Corp. a pharmaceutical company specializing in precision-based cannabinoids, is pleased to announce it has launched the new Shake & Puff CBN THC Nighttime Inhaler in Canada. This innovative product expands MediPharm’s leading CBN...

Haleon’s Otrivin® Brand Now Features Aptar’s First Nasal Pump Made with 52% Bio-based Material

Aptar Pharma, a global leader in drug delivery and active material science solutions and services, is proud to announce that its Freepod® nasal spray pump - one of the delivery systems for Haleon's Otrivin® brand - is now made with mass balance...

Made Scientific and Sentinel BioTherapeutics Announce a Strategic Manufacturing Partnership to Advance the Phase I/II Allogeneic ePP Encapsulated Cell Therapy Program

Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumors,...

Hengrui’s Heng Qin® (Perfluorohexyloctane Eye Drops) Approved as the First Treatment for Dry Eye Disease Associated with MGD—A Breakthrough in Ophthalmology

Jiangsu Hengrui Pharmaceuticals Co., Ltd. a global pharmaceutical company focused on scientific and technological innovation, and Novaliq GmbH (“Novaliq”), a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based...

Innovent Announces Approval from China's NMPA for Mazdutide, the First Dual GCG/GLP-1 Receptor Agonist, for Chronic Weight Management

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major...

With New Offerings Like MIC+B12 Injections, Metformin Combinations, and More, Shed Expands Its Weight Management Support

Shed, a modern wellness company focused on helping individuals feel and function their best, announces the launch of several new products designed to provide affordable, weight management support options for individuals at every stage of their...

enGene’s Detalimogene Receives RMAT Designation from the FDA, Opening the Path for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also...

Boehringer Ingelheim and the Lung Cancer Research Foundation Announce New Research Collaboration

The Lung Cancer Research Foundation (LCRF) announces a new research collaboration with Boehringer Ingelheim creating two funding mechanisms designed to address HER2 mutations in lung cancer: a new Team Science Award and an Early Career...

Ratio Therapeutics partners with Macrocyclics for exclusive production and global distribution of its Macropa™ radiopharmaceutical platform

Ratio Therapeutics Inc. (Ratio), a pharmaceutical company employing innovative technologies to develop best-in-class radiopharmaceuticals for cancer treatment and monitoring, announced today that it entered into an agreement granting Macrocyclics...

Nuvation Bio’s IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive non-small cell lung cancer, has been approved by the U.S. Food and Drug Administration

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...

Lubrizol reveals a significant milestone for its innovative, patented Apisolex™ polymer excipient

Lubrizol announces that an Apisolex™ polymer excipient-enabled drug formulation is in Phase 1 clinical trials. Introduced to the market in 2022, Apisolex polymer excipient is a polyamino acid-based polymer that enhances the solubility of BCS Class...

A New Production Line Dedicated to Sterile Hyaluronic Acid Has Been Inaugurated by HTL Biotechnology

On the occasion of National Bioproduction and Biomedicines Day (JNBB), which enjoys the high patronage of the President of the French Republic, HTL Biotechnology confirms its position as a globalleader in the development and production of...

Samsung Bioepis and Organon’s HADLIMA™ Gains FDA Interchangeability Designation, Expanding Access to Adalimumab Alternative

Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...