Drug Approval | October 14, 2024
Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3
Indoco is comprehensively working on the remedial action plan
Indoco is comprehensively working on the remedial action plan
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis
The company can now expand its business horizon into the area of pharmaceutical applications in the USA
The inspection concluded with the issuance of a form 483 with five observations
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)
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
A first-in-class muscarinic agonist for the treatment of schizophrenia in adults
The company will also share results in two additional posters for deuruxolitinib
These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity
Doses will be ready to ship to applicable European Union (EU) member states as soon as possible upon European Commission (EC) authorization
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