IPP Bureau
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
By IPP Bureau - September 30, 2024
The inspection concluded with the issuance of a form 483 with five observations
USFDA inspection update on Jubilant HollisterStier’s Montreal facility
By IPP Bureau - September 30, 2024
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
Dr. Reddy's invests US$ 620 million in Switzerland subsidiary
By IPP Bureau - September 30, 2024
Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
By IPP Bureau - September 29, 2024
Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations
Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA
By IPP Bureau - September 29, 2024
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
Amcor's long-term SBTi targets confirmed
By IPP Bureau - September 28, 2024
The net-zero target approval complements the company's near-term emission reduction targets
Lupin signs distribution agreement with Celnova for orphan drug NaMuscla
By IPP Bureau - September 28, 2024
Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia
AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
By IPP Bureau - September 28, 2024
Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression
FDA approves Bristol Myers Squibb’s Cobenfy
By IPP Bureau - September 28, 2024
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
Baxter launches nextgen airway clearance system
By IPP Bureau - September 28, 2024
Developed in consultation with clinicians and patients for an enhanced user experience
Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg
By IPP Bureau - September 28, 2024
Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
AIIA starts “Ayurveda innovation for Global Health” campaign
By IPP Bureau - September 28, 2024
Potential of Ayurveda’s contribution in global health system through various innovative practices
India releases revised operational guidelines of non-alcoholic fatty liver disease
By IPP Bureau - September 28, 2024
India has taken the lead in recognising NAFLD as a major non-communicable disease
India reaffirms commitment to social determinants of health at UNGA
By IPP Bureau - September 28, 2024
India called for stronger investments in health and social equity at G20 Joint Finance-Health Task Force Meeting
