Tagrisso recommended for approval in the EU for unresectable EGFR-mutated lung cancer

Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years

USFDA approves first gene therapy for treatment of aromatic L-amino acid decarboxylase deficiency

Aromatic L-amino acid decarboxylase deficiency is a rare genetic disorder that affects the production of some neurotransmitters

Merck receives positive EU CHMP opinion for pembrolizumab plus chemotherapy as first-line treatment for unresectable non-epithelioid MPM

Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial

EMA grants GMP Certificate of compliance to CuraTeQ biosimilars’ Hyderabad facility

The GMP inspection assessed mammalian and microbial drug substance manufacturing facility sections

Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

Granules India’s Unit V facility secures USFDA EIR with NAI status

The FDA conducted a comprehensive Pre-Approval Inspection (PAI) and cGMP audit

Lupin receives tentative approval from USFDA for Raltegravir Tablets

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

USFDA inspection of Shilpa Medicare Unit VI at Bengaluru

The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature

Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV

Company receives acceptability, in principle, for ZyVac TCV making it eligible for purchase by United Nations procurement agencies

Alembic receives USFDA final approval for Diltiazem Hydrochloride ER capsules

Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension

Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg

Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad

Granules India receives ANDA approval for Bupropion Hydrochloride ER Tablets

Granules now has a total of 67 ANDA approvals from the USFDA

FDA approves VYALEV for adults living with advanced parkinson's disease

VYALEV is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease

Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic NSCLC

Enhertu demonstrated clinically meaningful efficacy in previously treated patients

Shilpa Medicare’s CDMO customer gets fast-track designation for its investigational drug candidate

GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally

Lyka’s patent pending Drug Pregabalin Gel 8% w/w receives approval from CDSCO

Lyka has received the CDSCO approval for manufacturing and marketing of Pregabalin Gel 8% w/w

Indoco Remedies receives OAI status from USFDA for Goa plant 2 & 3

Indoco is comprehensively working on the remedial action plan

USFDA approves Pfizer’s marstacimab-hncq for treatment of hemophilia A or B

HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis

Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad