Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 29
Drug Approval
Drug Approval | 28 June 2022

Lynparza gets positive opinion from EU CHMP as adjuvant treatment for germline BRCA-mutated early breast cancer

First and only PARP inhibitor to improve invasive disease-free survival in patients

Drug Approval
Drug Approval | 27 June 2022

Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease

The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects

Drug Approval
Drug Approval | 24 June 2022

Novartis receives EC approval for Tabrecta for the treatment of non-small cell lung cancer

Tabrecta is the number one prescribed targeted therapy for advanced NSCLC with alterations leading to METex14 skipping globally

Drug Approval
Drug Approval | 24 June 2022

ANI Pharmaceuticals gets FDA approval of Clorazepate Dipotassium Tablets USP

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene.

Drug Approval
Drug Approval | 24 June 2022

Rivaroxaban approved in Japan for patients with PAD after revascularisation

It´s the first trial to demonstrate the benefits of dual pathway inhibition

Drug Approval
Drug Approval | 23 June 2022

Menarini Group and Radius Health submit new drug application to the USFDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients

Drug Approval
Drug Approval | 16 June 2022

Stelis Biopharma's two biologics manufacturing facilities receive EU cGMP accreditation

Stelis's small-scale cGMP manufacturing facility is designed to support smallscale commercial and cGMP clinical trial material generation

Drug Approval
Drug Approval | 15 June 2022

Eli Lilly gets FDA approval for alopecia drug

Alopecia areata usually presents as a few small bald patches in the head

Drug Approval
Drug Approval | 14 June 2022

FDA accepts application for Merck’s Keytruda as adjuvant therapy for Stage IB-IIIA lung cancer

Acceptance based on results from the phase 3 KEYNOTE-091 trial

Drug Approval
Drug Approval | 12 June 2022

Alembic receives USFDA tentative approval for Dasatinib tablets

Dasatinib Tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive

Drug Approval
Drug Approval | 12 June 2022

Strides receives USFDA approval for Ibuprofen OTC oral suspension

Strides was granted a Competitive Generic Therapy (CGT) designation for its ANDA.

Drug Approval
Drug Approval | 12 June 2022

China NMPA approves Tislelizumab for metastatic nasopharyngeal cancer

Tislelizumab is now approved in nine indications in China

Drug Approval
Drug Approval | 10 June 2022

Sanofi Dupixent gets USFDA nod for atopic dermatitis

Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy to adulthood

Drug Approval
Drug Approval | 09 June 2022

Sumitomo Pharma Oncology receives orphan drug designation for the treatment of myelofibrosis

TP-3654 is currently being evaluated in a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with intermediate or high-risk primary or secondary myelofibrosis.

Drug Approval
Drug Approval | 08 June 2022

Eugia Pharma receives USFDA Approval for Leuprolide Acetate Injection

he approved product has an estimated market size of US$ 83 million for the twelve months ending April 2022, according to IQVIA.

Drug Approval
Drug Approval | 08 June 2022

Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.

Drug Approval
Drug Approval | 07 June 2022

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad

Drug Approval
Drug Approval | 06 June 2022

FDA publishes ANP’s polymeric drug excipient DMF

The DMF#36513 demonstrates ANP’s success in the development of its “Plug and Play” drug delivery platform.

Drug Approval
Drug Approval | 01 June 2022

ENTOD Pharmaceuticals gets DCGI nod to carry out the phase 3 trials of 0.05% atropine eye drops

Low-dose atropine has emerged as an effective approach to slow the progression of myopia in children

Drug Approval
Drug Approval | 01 June 2022

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved

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