Drug Approval | December 17, 2025
Lupin receives EIR from USFDA for Nagpur injectable facility
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
India plays a critical role in Bristol Myers Squibb’s global strategy
The upcoming trials will evaluate both active and chronic TED in randomized, double-blind, placebo-controlled studies
The randomized, double-blind, placebo-controlled single ascending dose (SAD) study evaluated safety, tolerability, pharmacokinetics, and target engagement in 46 healthy participants
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
The approval of Nuzolvence (zoliflodacin) follows a collaborative development effort with the Global Antibiotic Research and Development Partnership
Ryght AI tackles these hurdles with its AI Site Twin platform
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Dr Srivastava was selected by an expert jury in recognition of her sustained contributions to renewable chemicals, industrial biotechnology and bioprocess innovation
The reform is set to modernise how medicines are developed, authorised, and made available across the EU
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