Natco Pharma receives 8 observations from USFDA for Pharma Division at Kothur

The company is confident of addressing all the observations within the stipulated time

Daiichi Sankyo, Merck collaborate to develop and commercialize three Daiichi Sankyo DXd ADCs

Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months

USFDA approves Pfizer’s Velsipity for adults with Ulcerative Colitis

Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials

USFDA inspection at Biocon Biologics' manufacturing facility in Johor, Malaysia

Glenmark receives ANDA approval for Apremilast Tablets

Glenmark's current portfolio consists of 188 products authorized for distribution in the US

Lupin enters into BTA with Lupin Manufacturing Solutions

Lupin enters into BTA with Lupin Manufacturing Solutions

Sirio Pharma and Best Formulations announce US gummy manufacturing capabilities

The new gummy capabilities include a dedicated R&D lab, an automated production line, and bottle packaging solutions

Dr Reddy's Bachupally biologics facility gets USFDA Form 483 with 9 observations

The USFDA inspectors issued the observations after a product pre-approval inspection of the biologics facility in Bachupally

Lupin gets tentative approval from USFDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch

Biocon Biologics gets complete response letter from USFDA for Biosimilar Insulin Aspart

The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022