Lupin receives USFDA approval for topical solution

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

USFDA approves first generic version of Apokyn cartridges

TruPharma has commenced commercial marketing of Sage's approved generic cartridge product

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022

Lupin launches Sevelamer Hydrochloride tablets in the United States

Sevelamer Hydrochloride tablets, 800 mg is a generic equivalent of Renagel tablets, 800 mg

USFDA approves CITI Biopharma’s Vonjo

Vonjo is the first approved therapy to specifically address the needs of adult cytopenic myelofibrosis patients

China’s NMPA accepts supplemental NDA for Carteyva

The sNDA was supported by the clinical results from cohort B of a single-arm, multi-center, pivotal study (RELIANCE study) on Carteyva in adult patients with relapsed or refractory B cell non-hodgkin lymphoma in China

Unichem receives ANDA approval for bipolar disorder drug

Divalproex Sodium Extended-Release tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches

First oral diabetes treatment approved in Europe for use during pregnancy

In a European work-sharing procedure (WSP), Glucophage was approved as the first oral anti-diabetic medication to be used safely from conception to birth

Japan approves Keytruda plus Lenvima for two types of cancer

Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.

Jardiance approved to treat adults with heart failure regardless of left ventricular ejection fraction

Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death or hospitalization for heart failure, regardless of ejection fraction

Zydus receives USFDA approval for Dapagliflozin tablets

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad

Prestige BioPharma’s Tuznue receives EU-GMP certification

UK MHRA approves Marksans All in One oral solution

Therapeutic use of the product is for short term symptomatic relief of colds, chills and influenza including chesty coughs

Strides receives USFDA approval for Amantadine Hydrochloride capsules

To be marketed by Strides Pharma Inc. in the US market

WHO grants prequalification of Actemra/RoActemra for critical COVID-19 patients

Since the beginning of the pandemic, more than one million patients with severe COVID-19 have been treated with Actemra/RoActemra

Poxel’s PXL065 granted FDA fast track designation for X-linked adrenoleukodystrophy

Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear

Amneal expands injectables portfolio with four new products

Launching Dexamethasone, Azacitidine, Carboprost, and Atropine for the Institutional Market

EC approves Tepmetko to treat non-small cell lung cancer

Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).

USFDA accepts Mirati Therapeutics' New Drug Application for Adagrasib

The Prescription Drug User Fee Action (PDUFA) date for adagrasib is December 14, 2022