Farxiga approved in the US for the treatment of paediatric type-2 diabetes

Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date

USFDA inspection of Lupin’s Nagpur injectable facility with zero 483 observations

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).

Torrent Pharmaceuticals gets Form 483 with 5 observations for Indrad facility

There was no observation related to data integrity reported

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace

IOL Chemicals receives EDQM CEP certificate for Pantoprazole Sodium Sesquihydrate and Allopurinol

EDQM has also issued a Certificate of Suitability for Allopurino

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus

Orchid Pharma receives DCGI approval for combination of Cefepime and Enmetazobactam

DCGI has also granted permission to manufacture and market FDF of Cefepime and Enmetazobactam as a dry powder injectable

Shilpa Biologicals files Type IV DMF of recombinant Human Albumin 20% with USFDA

This novel recombinant has been developed and is a patented novel recombinant Human Albumin 20% process

AstraZeneca’s Tagrisso plus chemo recommended for approval in EU

Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months

Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes

BlueRock Therapeutics receives FDA RMAT designation for Parkinson’s disease cell therapy candidate bemdaneprocel

Bemdaneprocel is the most clinically advanced investigational cell therapy in the U.S. for treating patients living with Parkinson’s disease

FDA grants priority review to Merck’s application for Keytruda plus chemotherapy for metastatic malignant pleural mesothelioma

Acceptance based on results demonstrated a statistically significant improvement in overall survival versus chemotherapy alone in these patients

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death

Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL

Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation

Zydus receives final approval from USFDA for Theophylline ER Tablets

Theophylline is used to treat asthma and chronic obstructive pulmonary disease

Cipla receives final approval for the generic version of Somatuline Depot Injection

Cipla's Lanreotide Injection is AP-rated therapeutic equivalent generic version of Somatuline Depot (Lanreotide) Injection

Biocon Biologics’ receives FDA approval for Biosimilar Aflibercept for Yesafili

The approval of YESAFILI marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States

Glenmark receives ANDA approval for Brimonidine Tartrate and Timolol Maleate ophthalmic solution

According to IQVIATM sales data for the 12-month period ending March 2024, the Combigan Ophthalmic Solution, 0.2%|0.5% market achieved annual sales of approximately $290.0 million

Moderna update on investigational RSV vaccine

U.S. FDA has informed Moderna that due to administrative constraints, the agency will not complete its review of mRNA-1345 by the PDUFA date of May 12, 2024