Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated

FDA approves Merck's Keytruda injection for cancer therapy

Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations

FDA approves Lupin’s Lenalidomide capsules

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma

Biocon Biologics receives FDA approval for Bosaya and Aukelso biosimilars

FDA grants breakthrough therapy designation to R-DXd for platinum-resistant ovarian and related cancers

Raludotatug deruxtecan is a specifically engineered, potential first-in-class CDH6-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo

Rona submits IND for GalNAc-conjugated siRNA targeting obesity

RN3161 is engineered to reduce fat while preserving lean mass, setting it apart from current treatment options

FDA approves Corstasis’ bumetanide nasal spray to treat edema in heart, liver, and kidney disease

Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China

This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav

Mankind Pharma gets CDSCO nod to begin Phase 1 trials of novel Autoimmune drug candidate MKP11093

MKP11093 has shown strong results in preclinical studies with a promising safety and selectivity profile

FDA prohibits Sun Pharma's Halol Plant from exporting drugs to US

Sun Pharma's Halol plant gets OAI classification from US FDA inspection

Alembic gets FDA final approval for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe

FDA grants Fast Track Designation for Teva’s Emrusolmin

Teva received Fast Track designation from the U.S. Food and Drug Administration for emrusolmin (TEV-56286), an investigational treatment for Multiple System Atrophy (MSA) in Phase 2 development

USFDA conducts product specific pre-approval inspection at Lupin’s Aurangabad facility

Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe

FDA approves sBLA for Takeda's Vonvendi for Von Willebrand disease

Vonvendi is the only recombinant Von Willebrand factor replacement therapy with approved indications in adults and children with VWD

FDA expands medtronic MiniMed 780G system

Now integrates with Abbott’s instinct sensor and approved for type 2 diabetes

Lupin receives FDA approval for Risperidone LAI with 180-day CGT exclusivity

This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity

Caplin Steriles granted final approval for ANDA Milrinone Lactate in 5% Dextrose Injection by USFDA

Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure

FDA grants accelerated approval to Zongertinib for HER2-mutated non-squamous NSCLC

New targeted therapy offers hope for patients with unresectable or metastatic NSCLC harboring HER2 tyrosine kinase domain activating mutations