Mac-Chem Products (India)’s Boisar facility renews EU-GMP certification

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met

AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine

Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024

Novartis reports data from trial of IgA nephropathy treatment

IgAN is a heterogeneous, progressive, rare kidney disease and is a major cause of chronic kidney disease worldwide

Teva confirms efficacy and safety of Ajovy for prevention of migraine

Ajovy confirms efficacy in new Phase 3 data significantly reducing the number of migraine days per month

Lupin launches first generic version of Oracea in US

Doxycycline Capsules, 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients

Abbott receives FDA approval for TriClip

TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery

EC expands Reblozyl’s approval for treatment of myelodysplastic syndromes

This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024