Drug Approval | February 27, 2025
USFDA issues Form 483 with 3 observations to Gland Pharma's Sterile APIs unit
The observations issued are neither repeated observations nor related to data integrity
The observations issued are neither repeated observations nor related to data integrity
Eleven CRDMOs collaborate to form IPSO with the aim to elevate India’s position in the global pharmaceutical value-chain
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
Cipla Limited has received final approval from the USFDA for the New Drug Application submitted for ‘Nilotinib Capsules 50, 150 and 200 mg’
Sarat Kumar has been appointed as CFO of the company and also designated as Key Managerial Personnel with effect from February 21, 2025
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease
Innovative chronic pain treatment receives IP protection in India's $55 billion pharmaceutical market
Revenue up 11% to Rs 5,768 crore as compared to Rs 5,197 crore
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries
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