Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 154

Results For "NDA"

4061 News Found

Zydus receives final approval from USFDA for Tretinoin Cream
Drug Approval | April 28, 2024

Zydus receives final approval from USFDA for Tretinoin Cream

The drug will be manufactured at the group's topical manufacturing facility at Changodar, Ahmedabad (India)


Evonik expands capacity for customized Resomer powder biomaterials
News | April 28, 2024

Evonik expands capacity for customized Resomer powder biomaterials

New solvent-free micronization technology expanded at the Darmstadt site in Germany


CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine
Drug Approval | April 27, 2024

CHMP adopts positive opinion recommending approval of Bristol Myers Squibb’s Opdivo in combination with Cisplatin and Gemcitabine

If approved, the Opdivo-based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU


FDA approves Biktarvy label update with data for pregnant adults with HIV
Drug Approval | April 27, 2024

FDA approves Biktarvy label update with data for pregnant adults with HIV

Additional data in pregnant adults who are Virologically suppressed reinforce safety and tolerability profile of Biktarvy in broad range of people with HIV


Merck 1Q 2024 sales up 9% to US$ 15.8 billion
News | April 26, 2024

Merck 1Q 2024 sales up 9% to US$ 15.8 billion

Sales reflect continued strong growth in oncology and vaccines


New chemical method could cut waste from drug production
News | April 25, 2024

New chemical method could cut waste from drug production

One form of thalidomide has the intended sedative effect but the opposite mirror-image form interferes with foetal development


Bristol Myers Squibb and Cellares inks US$ 380 million capacity reservation for the manufacture of CAR T Cell Therapies
News | April 23, 2024

Bristol Myers Squibb and Cellares inks US$ 380 million capacity reservation for the manufacture of CAR T Cell Therapies

Cellares will dedicate multiple Cell Shuttle and Cell Q systems with fully automated, high-throughput quality control for Bristol Myers Squibb’s exclusive use


Voydeya approved in the EU as add-on treatment to ravulizumab
News | April 23, 2024

Voydeya approved in the EU as add-on treatment to ravulizumab

ALPHA Phase III trial showed first-in-class, oral, Factor D inhibitor as add-on to Ultomiris or Soliris improved haemoglobin levels and reduced anaemia and fatigue


Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings
Drug Approval | April 23, 2024

Zydus’ new drug application of Desidustat tablets accepted by China Medical System Holdings

Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients


Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines
Drug Approval | April 23, 2024

Kwality Pharmaceuticals receives approval from INVIMA for Ampoule and Vial product lines

Approval from Colombia's INVIMA will accelerate growth in Colombia, by registering our product and getting regular supplies