2025, ifinatamab deruxtecan was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with ES-SCLC with disease progression on or after platinum-based chemotherapy....
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®) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting...
The facility has been successfully inspected and approved by leading global regulatory agencies including the USFDA, PMDA (Japan), and CDSCO (India). As of March 2025, Sai Life Sciences’ manufacturing units had undergone over 75 customer audits in...
autoimmune, ophthalmology and other major therapeutic areas, announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to initiate a global Phase 3 clinical trial (MarsLight-11) of IBI363...
Theravance is preparing for an expedited NDA submission following the results and is planning to request priority FDA review, if data are supportive. This milestone reinforces our strategic focus and delivers on Theravance's commitment to advancing...
Ltd. announced that it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VTB-10, its drug candidate for pulmonary arterial hypertension (PAH), a rare,...
This collaboration represents a significant milestone in improving access and affordability of these important, authentic, FDA-approved medications. “Improving access to effective FDA-approved treatment is central to our mission, and our...
and offer a proven path to commercialization. They are also safe, fast, and easy-to-use. The Stratis® System has U.S. FDA 510(k) marketing clearance, CE Mark, and WHO PQS certification to deliver medications and vaccines either intramuscularly or...
outcomes, are significant and meaningful from the perspective of the patient community. Currently, there is no U.S. FDA-approved therapy for the treatment of MPS IIIB, and disease management consists of limited palliative care. We are eager to see...
a clinical-stage biotechnology company, and Bristol Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted. Breakthrough Therapy Designation (BTD) to izalontamab brengitecan (iza-bren) for the treatment of locally...
pulmonary fibrosis (Bersiporocin), which has received both orphan drug designation and Fast Track status from the US FDA. About Daewoong Therapeutics: Daewoong Therapeutics Inc., is a subsidiary of Daewoong Group located in South Korea. The company...
Viatris Inc. a global healthcare company, announced the U.S. Food and Drug Administration (FDA) has approved Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia (IDA) in adult and pediatric...
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 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...
This GMP license was the first step in the Company’s current foreign drug manufacturing site registration with the US FDA. In 2023, MediPharm acquired VIVO Cannabis Inc., which expanded MediPharm’s reach to medical patients in Canada via Canna...
Apellis Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis...
BD Libertas™ Wearable Injector is a device component intended for drug-device combination products and not subject to FDA 510(k) clearance or separate EU CE mark certification. About BD: BD is one of the largest global medical technology companies...
Company is supported by a global network of development and contract manufacturing partners that have undergone successful FDA inspections based on cGMP standards. About Avenacy: Avenacy is a U.S.-based specialty pharmaceutical company focused on...
Injection, and Ketamine Injection. "Butorphic's launch reinforces our position among the animal health leaders in U.S. FDA ANADA approvals over the past several years, which is a testament to our team’s dedication to delivering high-quality,...
Areata Foundation (NAAF). "NAAF is thrilled to see expanded choices and increased opportunities for individuals to find an FDA-approved treatment to address hair loss caused by this autoimmune disease." LEQSELVI may cause serious side effects...
