Lupin receives tentative approval from FDA for Ivacaftor tablets

Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.

Zydus Lifesciences receives USFDA approval for Adapalene and Benzoyl Peroxide Topical Gel

The drug will be manufactured at the group’s topical facility at Ahmedabad

FDA publishes ANP’s polymeric drug excipient DMF

The DMF#36513 demonstrates ANP’s success in the development of its “Plug and Play” drug delivery platform.

USFDA accepts dupilumab for priority review in adults with prurigo nodularis

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved

FDA approves Roche’s Evrysdi for use in babies under two months with SMA

Evrysdi has proven efficacy in babies, children and adults with more than 5,000 patients treated to date

Mezzion Pharma receives clear FDA path forward for the approval of Udenafil for single ventricle heart disease

US FDA accepts new drug application filed by Avillion for AstraZeneca's PT027

Avillion announces expansion of partnership with AstraZeneca on PT027 and will fund and execute a new Phase 3b study

Strides receives USFDA approval for Ibuprofen Oral Suspension

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Motrin Oral Suspension, 100 mg/5 mL, of McNeil Consumer Healthcare (McNeil)

Zydus receives EIR from USFDA for its injectables manufacturing facility at Jarod

The inspection was a Pre-Approval cum cGMP inspection and it covered 15 ANDAs

USFDA approves two Opdivo-based regimens

Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers