Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study

BMS’s anti-MTBR-Tau granted fast track designation by FDA for Alzheimer’s disease

Anti-microtubule binding region-tau antibody being investigated as a potential disease-modifying therapy to slow or delay progression of disease

Takeda exits cell therapy research

Takeda will seek an external partner to leverage its cell therapy platform technologies

AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder

Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors

Lupin launches Liraglutide injection in US

Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk

Briefs: Panacea Biotec, Lotus Eye Hospital and Uflex

Panacea Biotec receives Rs. 315 crore LoA from UNICEF

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

IPA welcomes Dr. Sharvil Patel as President and Glenn Saldanha as Vice President