Drug Approval | September 30, 2024
USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
The inspection concluded with the issuance of a form 483 with five observations
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
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous
This Fast Track Designation will enable FDA to review MM-II in an expedited manner, is an important milestone in the development of MM-II
TABRECTA is the brand of Novartis. Natco believes it is the first company to have filed a substantially-complete ANDA
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