CDSCO rolls out prior intimation system to fast-track drug testing and R&D

Shift from approvals to digital intimation via NSWS portal aims to cut timelines and boost innovation in early-stage drug development

Aurobindo Pharma bags USFDA nod for Glycerol Phenylbutyrate Oral Liquid

The approved product is a generic version of Ravicti, originally developed and marketed by Horizon Therapeutics

Aurobindo Pharma wins key FDA nod for $138M US cough drug market entry

The drug is designed to provide temporary relief from cough caused by throat and bronchial irritation

Aurobindo Pharma wins USFDA nod for rare disease drug set for immediate launch

Cipla receives two observations following USFDA inspection at Goa facility

The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe

Morepen Laboratories secures fourth consecutive USFDA ‘NIL 483’ inspection

Zero-observation outcomes strengthen global credibility and accelerate CDMO ambitions

FDA grants priority review to Daiichi Sankyo & Merck’s lung cancer drug application

The investigational therapy, ifinatamab deruxtecan, is a potential first-in-class B7-H3 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck

MSN Laboratories launches SEMABEST, India-made semaglutide pen at nearly 50% lower price

CDSCO-approved therapy enters India’s fast-growing post-patent GLP-1 market with fully integrated API, formulation and pen manufacturing

CDSCO invites bids for next-gen Digital Drugs Regulatory System

API-first, DPI-driven DDRS platform aims to modernize drug and medical device regulation in India

CDSCO reforms cut trial approval timelines by over 50%: DCGI Dr Rajeev Raghuvanshi

Outlines 1,500-member internal cadre, digital regulatory system, and faster SEC-led reviews

FDA fast-tracks Daiichi Sankyo & Merck lung cancer drug review

The FDA is also reviewing the application under its Real-Time Oncology Review (RTOR) program and Project Orbis

Orbicular, Apotex win tentative USFDA nod for generic Ozempic

Hyderabad-based peptide specialist strengthens complex generics credentials as Apotex prepares for U.S. commercialization of semaglutide injection

Lupin scores major US breakthrough with FDA nod for key diabetes drug

The Abbreviated New Drug Application with FDA covers multiple strengths of Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets

Glenmark gets USFDA approval for generic Endometrin vaginal inserts

Final approval for progesterone vaginal inserts expands Glenmark’s women’s healthcare portfolio in the US, targeting a market of over $59 million

India’s Dapagliflozin Moment: Why USFDA’s generic greenlight wave matters

In just the last few days, companies including Lupin, Biocon, Alembic Pharmaceuticals and Aurobindo Pharma have announced approvals for 5 mg and 10 mg tablets, all bioequivalent to Farxiga

Lupin wins USFDA nod for generic Dapagliflozin tablets

Approval for 5 mg and 10 mg strengths, bioequivalent to Farxiga®, strengthens Lupin’s anti-diabetic portfolio in US market

Aurobindo gets USFDA approval for Dapagliflozin with 180-day exclusivity

Immediate U.S. launch planned for Farxiga®-equivalent diabetes drug; opportunity pegged at $10.2 billion in annual market size

Aurobindo Pharma wins USFDA approval for generic Xigduo XR

Immediate U.S. launch planned for dapagliflozin-metformin ER tablets; addressable market estimated at $514 millionannually

Zydus gets USFDA final approval for generic Dapagliflozin with 180-day shared exclusivity

Immediate opportunity in the $10.2 billion U.S. market as the diabetes therapy will be manufactured at Zydus’ SEZ Ahmedabad facility

Alembic Pharma wins USFDA nod for generic Dapagliflozin, secures 180-day exclusivity

Final approval for diabetes and heart-failure drug opens access to a $10.5 billion US market opportunity, with shared exclusivity benefits.