US tariff threats on Indian generic drugs face significant obstacles. These duties could increase American healthcare costs and potentially...

Natalie Harp has become a key aide to Donald Trump since joining his staff. She now manages communications and drafts his social media post...

Natalie Harp, an executive assistant, faces political controversy over her close access to Donald Trump. Senator Jon Ossoff's remarks ignit...

Capricor Therapeutics shares surged significantly after the FDA agreed to review new drug data. The company had faced setbacks last month r...

Donald Trump's proposed up to 200% tariff on generic drug imports has raised concerns for Indian pharma companies, but industry experts say...

The Central Drugs Standard Control Organisation (CDSCO) plans to create a 1,500-member scientific cadre to speed up drug approval timelines...

New drugs are not reaching low and middle income countries. A study shows many medicines take years to become accessible globally. India's ...

Wockhardt’s breakthrough respiratory drug Zaynich moves a step closer to market as the US FDA accepts it for review, boosting approval odds...

Ocugen in a statement on Thursday announced that as recommended by theFDA,it will pursue submission of a biologics licence application (BLA...

This follows the recommendation of the USFDA and it means that, subject to regulatory approvals, it will take a longer time for Covaxin to ...

Fulphila is expected to contribute to Biocon’s revenue in FY19, as well as to its profits through a profitshare arrangement with Mylan.

Analysts largely believe the near-term earnings in the sector will largely be a function of new launches in the US and growth rates in dome...

The approval of several of Sun's key drugs in the United States, the drugmaker's biggest market, depends on the clearance on its Halol plan...

Dr. Reddy’s informed stock exchanges that 3 of its key sites received warning letters from US FDA and will need to submit correction plans ...

A long spell of sluggish approvals for generic drugs in the US may be nearing an end with early signs of a rebound.

The Generic Drug User Fee Act (GDUFA) in the US was proposed to expedite the approval of generic drugs on collecting higher fees to process...

The move comes after Ranbaxy said that FDA had stripped the company of its tentative approval to launch the first copy of the drug.