Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru

Evive Biotech and Acrotech Biopharma receive FDA approval of Ryzneuta

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US

Lupin receives approval from USFDA for Pitavastatin Tablets

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024

Strides receives USFDA approval for Levetiracetam Oral Solution

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.

Lupin receives approval from US FDA for Ganirelix Acetate Injection

The product will be manufactured at Lupin’s Nagpur facility in India

Teva announces approval of a generic version of Forteo in US

This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer

Imfinzi plus chemotherapy approved in China as for metastatic biliary tract cancer

Approval based on results from TOPAZ-1 global Phase III trial and a Chinese patient

Kesin Pharma announces FDA approval and availability of Likmez oral suspension

Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).

Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets

This product will be manufactured at Lupin’s Pithampur facility in India

Lupin receives tentative approval from USFDA for Selexipag for injection

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

NATCO Pharma announces successful completion of USFDA inspection

NATCO's Pharmacovigilance Department was inspected from October 30, 2023 to November 1, 2023

Lupin Mandideep plant gets USFDA green signal

The inspection of the facility conducted from August 7 to August 11, 2023

Enhertu approved in the EU as the first HER2-directed therapy for patients with HER2-mutant advanced non-small cell lung cancer

Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients