Fda Approval News

Market

High drug approvals to keep up pricing pressure for pharma firms

Competition and price erosion have triggered a rethink among firmsFilings for drug approvals slowed in October and November

1 min read19 Jan 2019
Market

Shilpa Medicare gets USFDA nod for cancer treatment injection

Shilpa Medicare said it has received approval from the US health regulator for Irinotecan HCL injection, used for treatment of certain kind of cancers

1 min read1 Jan 2019
Industry

US FDA nod to Sun Pharma’s glaucoma drug

XELPROS will be commercialised in the US by Sun Ophthalmics, the branded ophthalmic division of Sun Pharma

1 min read14 Sep 2018
Market

Rally in pharma shares in June could prove to be a false start

Investors should not get carried away by the tide of rising sentiment in favour of pharmaceutical stocks

2 min read19 Jun 2018
Companies

Indivior shares dive after Dr Reddy’s gets US FDA approval for generic

Dr Reddy's said it would launch its generic version of Suboxone, a composition of buprenorphine and naloxone, at risk, with an approved REMS program

1 min read15 Jun 2018
Companies

Glenmark gets US FDA approval for Loestrin generic version

The approved products are generic versions of Allergan Pharmaceuticals' Loestrin 21 1.5/30 and Loestrin Fe 1.5/30 tablets

1 min read6 Jun 2018
Market

Cipla Q4 FY18 results no reason to reverse stock underperformance

The US generics pain is unlikely to subside anytime soon despite optimistic commentary from Cipla due to the growing number of USFDA approvals

2 min read23 May 2018
Market

Sun Pharma: One down, Halol to go

Sun Pharma has passed a key milestone with the Ilumya drug approval, but its investors seem to be fixated on its ability to get the USFDA approval for the Halol plant

3 min read23 Mar 2018
Companies

Divi’s Lab Vizag unit gets USFDA inspection report with 6 observations

Divi's lab says it has received an establishment inspection report (EIR) from US health regulator for its unit-II in Visakhapatnam, as closure of audit by USFDA

1 min read18 Nov 2017
Market

Natco Pharma’s generic pipeline delivers a blockbuster

The US FDA approval to launch Mylan-made Copaxone’s generic version adds more credibility to Natco Pharma’s generic drug pipeline

2 min read5 Oct 2017
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