The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.
Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A
Difluprednate Ophthalmic Emulsion, 0.05% is a topical corticosteroid that is indicated in the treatment of inflammation and pain associated with ocular surgery
Demonstrates vision gains with extended treatment intervals in retinal vein occlusion
An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season
For people with relapsed or refractory diffuse large B-cell lymphoma
Launch of new product range aligns with strategy to diversify into emerging applications with high growth potential
The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections
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
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