Regulatory
Regulatory | 13 August 2022

Regen BioPharma develops novel dedifferentiation approach for increasing efficacy of CAR-T Cells to treat solid tumors

Company creates Younger T Cells for fighting cancer using its NR2F6 technology

Regulatory
Regulatory | 09 August 2022

ENHERTU approved in the U.S. as the first HER2 directed for low metastatic breast cancer

Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and increased overall survival by more than six months versus chemotherapy

Regulatory
Regulatory | 04 August 2022

Zydus receives final approval from the USFDA for Ivermectin Cream

Ivermectin Cream is a used for the treatment of inflammatory lesions of rosacea.

Regulatory
Regulatory | 04 August 2022

LYNPARZA approved in the EU as adjuvant treatment for early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

Regulatory
Regulatory | 03 August 2022

USFDA issues 3 observations for Aurobindo Pharma’s Unit XI

The company has responded to the warning letter and carried out the committed corrections.

Regulatory
Regulatory | 03 August 2022

Strides receives USFDA approval for Cyclosporine Softgel Capsules

Strides is the first Indian company to get approval for the product.

Regulatory
Regulatory | 31 July 2022

Casper Pharma completed USFDA pre-approval inspection

The audit is part of the agency's inspection for three product applications filed and slated to be manufactured at this site.

Regulatory
Regulatory | 31 July 2022

Shilpa Medicare's Unit III, Advanced Analytical Characterization Laboratory clears US FDA remote record review

The facility is designed with advanced analytical equipment to provide testing services such as In-vitro Permeation testing

Regulatory
Regulatory | 28 July 2022

Dr. Reddy's launches Bortezomib for Injection, 3.5 mg Single-Dose Vial in the U.S. Market

The Velcade Brand and generic had U.S. sales of approximately $1.2 billion MAT for the most recent twelve months ending in May 2022

Regulatory
Regulatory | 26 July 2022

Lupin receives approval from U.S. FDA for Azilsartan Medoxomil Tablets

The product will be manufactured at Lupin's facility in Nagpur, India.

Regulatory
Regulatory | 26 July 2022

Zydus receives final approval from the USFDA for Bisoprolol Fumarate Tablets

Bisoprolol Fumarate Tablets are used to treat high blood pressure.

Regulatory
Regulatory | 24 July 2022

SMS Pharmaceuticals receives approval for Ibuprofen by EDQM

With this, the company can start selling Ibuprofen in the European markets.

Regulatory
Regulatory | 24 July 2022

Dr. Reddy's announces the first-to-market, OTC launch of Allegra-D in the US market

Allegra-D had U.S. retail sales of approximately $45 million as of May 2022 according to IRI.

Regulatory
Regulatory | 20 July 2022

Brii Bio inks partnership with China Resources Pharmaceutical to advance the commercialization of Long-acting COVID-19 neutralizing antibody therapy

The partnership will accelerate stockpiling, channel distribution and hospital access for the amubarvimab/romlusevimab combination in China

Regulatory
Regulatory | 18 July 2022

Orchid Pharma updates on PLI scheme benefits for its subsidiary

The approval has been accorded by IFCI Limited for manufacturing of the product "7 ACA"

Regulatory
Regulatory | 18 July 2022

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).

Regulatory
Regulatory | 15 July 2022

U.S. FDA grants emergency use authorization for Novavax COVID-19 vaccine

Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.

Regulatory
Regulatory | 14 July 2022

USFDA removes Jubilant Generics' Olanzapine, Spironolactone and Valsartan from the excepted products list

Post this currently only Risperidone orally disintegrating tablets are allowed for import into the US from the Roorkee facility.

Regulatory
Regulatory | 14 July 2022

Shilpa Medicare’s Unit VI, Bengaluru facility has been issued UK MHRA GMP

The GMP facility is equipped with state of art machinery for the needs of Global commercial requirements

Regulatory
Regulatory | 12 July 2022

Zydus gets USFDA’s approval for Empagliflozin, Metformin Hydrochloride tablets

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

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