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10716 News Found

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA
Drug Approval | April 17, 2024

GSK’s 5-in-1 meningococcal ABCWY vaccine candidate accepted for regulatory review by US FDA

Submission based on results from pivotal phase III trial showing all primary endpoints met


Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution
Drug Approval | April 17, 2024

Caplin Steriles gets USFDA approval for Ofloxacin ophthalmic solution

Ofloxacin Ophthalmic Solution USP 0.3% is indicated for treatment of eye infections caused during the conditions of conjunctivitis and corneal ulcers


USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria
News | April 17, 2024

USFDA grants ODD to NM5072 for treatment of Paroxysmal Nocturnal Hemoglobinuria

NM5072 is an anti-Properdin antibody that selectively blocks the alternative pathway while maintaining the integrity of the classical pathway required for fending off infections


AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine
Clinical Trials | April 17, 2024

AbbVie announces late-breaking data at AAN supporting efficacy of Atogepant for preventive treatment of migraine

Interim analysis of an ongoing 156-week extension study supports long-term safety, tolerability and efficacy of atogepant 60 mg to prevent chronic and episodic migraine


AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer
Clinical Trials | April 17, 2024

AstraZeneca’s Imfinzi plus chemotherapy doubled overall survival rate for patients with advanced biliary tract cancer

Longest survival follow-up ever reported for immunotherapy treatment in this setting


Alvotech and Teva get US FDA approval of Selarsdi
Drug Approval | April 17, 2024

Alvotech and Teva get US FDA approval of Selarsdi

SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva


Positive data for Roche multiple sclerosis injection
Drug Approval | April 17, 2024

Positive data for Roche multiple sclerosis injection

US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024


Ami Organics accredited Gold Medal by EcoVadis
Sustainability | April 16, 2024

Ami Organics accredited Gold Medal by EcoVadis

The Gold Medal distinction places the company in the top 5% of all organizations assessed within EcoVadis's rigorous framework globally


Cipla Health strengthens its play in beauty and personal care
News | April 16, 2024

Cipla Health strengthens its play in beauty and personal care

CHL is strengthening its play in the fast-growing beauty and personal care sector


Moderna pauses plan to build mRNA manufacturing facility in Kenya
News | April 16, 2024

Moderna pauses plan to build mRNA manufacturing facility in Kenya

The demand in Africa for COVID-19 vaccines has declined