US FDA issues Form 483 to Cipla’s facility in MP
The FDA has censured the drug maker due to unclean equipment and lack of data
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US FDA
US FDA accepts New Drug Application for GSK’s momelotinib for treatment of myelofibrosis
Regulatory submission included data from the pivotal Momentum phase-III clinical trial that met all primary and key secondary…
US FDA says possible carcinogen found in some Merck diabetes drugs
The agency said it would temporarily allow Merck to distribute drugs with sitagliptin containing a higher than normally acceptable…
Glenmark gets US FDA nod for Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous…
These capsules are given to prevent pregnancy
GSK gets US FDA nod for Benlysta (Belimumab) to treat paediatric patients with active lupus…
Benlysta is now the first and only biologic approved for adults and children who have lupus or lupus nephritis
Zenara Pharma gets CDSCO nod to make and market generic version of Pfizer’s Paxlovid
The tablet, which will be sold under the brand name ‘Paxzen’, is being manufactured at Zenara’s US FDA approved facility in…
Pricing pressures, regulatory scrutiny prevail in US generics pharma industry: ICRA
ICRA expects mid to high single-digit price erosion to continue to exert pressure over the near term, resulting in muted revenue…
Lupin gets approval from US FDA for Azilsartan Medoxomil Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India.
NATCO gets ANDA approval for Cabazitaxel Intravenous Solution
Breckenridge and Natco did not divulge any more details regarding the launch date for the product
FDA grants priority review to Roche’s Lunsumio for Relapsed or Refractory Follicular Lymphoma
Approval is based on results from the pivotal phase-I/II clinical study of Lunsumio