Piramal Pharma gets Form 483 with 2 observations from USFDA for Lexington, USA facility

The observations do not pose any risk to site's compliance standards or its business continuity

Zydus receives WHO prequalification for Miltefosine formulation and API

Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies

Orchid Pharma's 'Exblifep' receives USFDA approval

Orchid is the first company from India, ever to have invented a product which has received a New Drug Approval (NDA) from USFDA

European Commission approves Pfizer’s Velsipity for patients with moderately to severely active ulcerative colitis

VELSIPITY is the first and only oral advanced ulcerative colitis therapy approved for use in patients 16 years of age or older in the EU

Lupin receives approval from USFDA for Minzoya

Minzoya Tablets are indicated for use by females of reproductive potential to prevent pregnancy

Zydus receives USFDA approval for Isosorbide Mononitrate Extended-Release, Tablets USP

Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition (coronary artery disease)

Ascentage Pharma’s Phase III study of Olverembatinib cleared by FDA

The US FDA's clearance of the trial marks the first global registrational Phase III trial for olverembatinib in patients with CP-CML to be conducted.

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions

Glenmark partners Pfizer to launch Abrocitinib in India

Developed by Pfizer, Abrocitinib has received marketing authorization from the Central Drugs Standard Control Organization (CDSCO) in India

Orchid Pharma's Exblifeb granted EMA approval

Exblifeb demonstrates remarkable efficacy in treating complicated Urinary Tract Infections (cUTI), pneumonia

Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours

Submission to be reviewed under FDA real-time oncology review and Project Orbis

EMA validates Type II variation application for enfortumab vedotin with pembrolizumab for treatment of bladder cancer

Pivotal trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall and progression-free survival

Shilpa Medicare updates on Europe GMP inspection at Unit 4, Jadcherla, Telangana

The company intends to respond to the two minor observations within the stipulated time

Zydus receives USFDA’s final approval for Gabapentin Tablets, 300 mg and 600 mg

Gabapentin is indicated for the management of Postherpetic Neuraligia

Strides receives USFDA approval for Pregabalin Capsules

The Pregabalin capsules has a market size of ~US$248 mn per IQVIA

Lupin receives tentative USFDA approval for Rivaroxaban Tablets USP

EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome

GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets

Lupin receives USFDA’s approval for Febuxostat Tablets

Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)