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1544 News Found

Lupin receives USFDA approval for topical solution
Drug Approval | March 03, 2022

Lupin receives USFDA approval for topical solution

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


USFDA issues new clinical trial guidelines for cancer treatments
News | March 02, 2022

USFDA issues new clinical trial guidelines for cancer treatments

USFDA's industry recommendations and cancer Moonshot aim to improve lives of patients and their families


USFDA approves first generic version of Apokyn cartridges
Drug Approval | March 02, 2022

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
Drug Approval | March 02, 2022

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

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


Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review
Biotech | March 01, 2022

Bristol Myers Squibb’s application for Opdivo plus chemotherapy receives USFDA priority review

If approved, Opdivo plus chemotherapy would be the first neoadjuvant immunotherapy-based option for patients with resectable non-small cell lung cancer in the U.S.


Lupin launches Sevelamer Hydrochloride tablets in the United States
Drug Approval | March 01, 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
Drug Approval | March 01, 2022

USFDA approves CITI Biopharma’s Vonjo

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


Unichem receives ANDA approval for bipolar disorder drug
Drug Approval | February 28, 2022

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


Europe clears blood test to predict Alzheimer’s disease
Medical Device | February 28, 2022

Europe clears blood test to predict Alzheimer’s disease

It is the first approved blood test that can predict likely progression to Alzheimer's Disease up to six years in advance


DiscGenics presents positive Phase1/2 study of Cell therapy for degenerative disc disease
Biotech | February 27, 2022

DiscGenics presents positive Phase1/2 study of Cell therapy for degenerative disc disease

Allogeneic discogenic cell therapy was well tolerated and produced clinically meaningful, statistically significant improvements in low back pain, function, and quality of life by 12 weeks following intradiscal injection