USFDA approves Merck’s ERVEBO for use in children 12 months of age and older

Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease

Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023

Zydus receives USFDA's final approval for Indomethacin Suppository with competitive generic therapy designation

Zydus' Indomethacin suppositories also been granted 180-day CGT exclusivity to market this product.

Lupin receives approval from US FDA for Turqoz

Norgestrel and Ethinyl Estradiol Tablets USP (RLD Lo/Ovral-28) had an estimated annual sale of USD 34 million in the U.S. (IQVIA MAT Mar 2023)

Jemperli plus chemotherapy approved in the US as the first new frontline treatment option for dMMR/MSI-H primary advanced or recurrent endometrial cancer

Jemperli is the only immuno-oncology treatment approved in the frontline setting for this patient population in combination with chemotherapy

USFDA accepts biologics license application for GC Biopharma's GC5107B

Eugia Pharma receives USFDA approval for Plerixafor Injection

The approved product has an estimated market size of around US$ 210 million for the twelve months ending May 2023

Lupin receives approval from TGA Australia for Tiotropium Dry Powder

Tiotropium (as bromide monohydrate) 18 micrograms powder for inhalation in capsule

NATCO files generic Erdafitinib Tablets in USA

Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma

AstraZeneca India receives permission from DCGI for Dapagliflozin

The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories

Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo will respond to the US FDA within the stipulated timelines

Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

This product would be manufactured at Lupin's Nagpur facility in India

Merck receives positive EU CHMP opinion for pembrolizumab plus Trastuzumab and Chemotherapy as first-line treatment for HER2-positive advanced gastric or gastroesophageal junction

If approved, KEYTRUDA would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ?1) in the EU

Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories

Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial

Lupin receives approval from USFDA for Chlorpromazine Hydrochloride Tablets USP

Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.

Granules India announces approval for Acetaminophen and Ibuprofen Tablets

This product will be launched through Granules Consumer Health (GCH) division

NMPA approval for first BCMA CAR-T Therapy paves way for more multiple myeloma cell therapies, says GlobalData

Approval to dramatically change CAR-T therapies landscape

Astellas receives FDA priority review for Zolbetuximab biologics license application

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients

Lupin receives tentative approval from USFDA for Dolutegravir Tablets for oral suspension

Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)