FDA IND Application Clearance to Hepion Pharma for its CRV431 in the Treatment of Liver Cancer
Summary – New IND Expands Liver Disease Pipeline for CRV431 IND Clearance Allows CRV431 to Move Directly into Phase 2 for Hepatocellular…
Regulatory
Aquestive Therapeutics Receives Notification from FDA for the Company’s NDA for Libervant™ (diazepam) Buccal Film
Synopsis : Received notification to Review of the New Drug Application (NDA) for Libervant™ (diazepam) Buccal Film for the treatment of breakthrough…
Intra-Cellular gets another FDA Nod for Caplyta, this time for Bipolar Disorder
Synopsis: CAPLYTA is the only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as…
USFDA Grant Orphan Drug Designation to Zydus ZY19489 Antimalarial Compound.
Synopsis- The ZY19489 is a novel antimalarial compound active against all current clinical strains of malaria-causing microorganisms ‘P. falciparum’ and ‘P. vivax’,…
USFDA Approves Generic Amphotericin B Liposome for Injection Manufactured By Sun Pharma
Synopsis- Sun Pharmaceuticals Industries announced that one of its wholly-owned subsidiaries has received final approval from US FDA for its Abbreviated New…
FDA Approves AstraZeneca’s Evusheld becomes First Authorized COVID Antibody to Protect the Immunocompromised Before Exposure
Summary : With the FDA’s emergency use authorization today of AstraZeneca’s long-acting antibody cocktail, the roughly 2% of U.S. residents who are…
INDIAN PESTICIDE APPROVAL UPDATES: 434th RC MEETING [CIBRC]
MINUTES OF THE 434th REGISTRATION COMMITTEE MEETING HELD ON 30.11.2021. The 434th meeting of the Registration Committee (RC) was held under the…
On Target Laboratories has received FDA Approval for the Injectable CYTALUXTM (Pafolacianine) for the Detection of Ovarian Cancer during Surgery.
The FDA has approved CYTALUX for adult patients with ovarian cancer as an adjunct for intraoperative identification of malignant lesions, according to…
Cipla Launches Naselin Nasal Spray to Fight Corona Virus
Cipla healthcare has launched Naselin antiviral nasal spray with Povidone Iodine that can offer the first line of defence against the COVID-causing…
Glenmark Pharmaceutical Launches First New Combination Drug for Type-2 Diabetes.
Glenmark Pharmaceuticals on Tuesday said it has launched a fixed-dose combination drug for the treatment of Type 2 diabetes in the country.…