The Latest Breaking News from FDA

Elektrofi and Immunoprecise Antibodies Ltd (NASDAQ:IPA) have collaborated to explore a high-concentration formulation of IPA's COVID-19 antibody cocktail, PolyTope TATX-03.  The collaboration aims to generate an IND-enabling data package for the FDA for an alternatively formulated version of TATX-03, named TATX-03E, that could be easily self-administered in a non-healthcare setting.  The parties anticipate formulating TATX-03E…

The FDA has extended the review period for Incyte Corporation's (NASDAQ:INCY) supplemental application for ruxolitinib cream (Opzelura) for vitiligo.  The Prescription Drug User Fee Act (PDUFA) action date has been extended by three months to July 18 from April 18. The FDA extended the PDUFA action date to review additional data from the ongoing Phase 3…

Under Sec. 741 of Division A(p.120), the U.S. Senate Committee on Appropriations has requested for the U.S.

Stringent FDA regulations imposed on nicotine consumption have hindered the tobacco industry’s growth over the past few years. However, manufacturers have produced various alternatives, like e-cigarettes, vapes, and similar smoking substitutes, which could help the industry grow. So, we think high dividend-yielding tobacco stocks Philip Morris (PM), British American (BTI),…

By John Vandermosten, CFA NASDAQ:ACHV READ THE FULL ACHV RESEARCH REPORT

The FDA has lifted the clinical hold on Immunome Inc's (NASDAQ:IMNM) Investigational New Drug (IND) application for its antibody cocktail (IMM-BCP-01) to treat COVID-19.  Immunome previously announced that the FDA had placed its IND application on clinical hold due to a request for further information related to the preparation and administration of IMM-BCP-01 at clinical sites. …

Memic Innovative Surgery Ltd has pulled out of a reverse merger deal with MedTech Acquisition Corporation (NASDAQ:MTAC), a special purpose acquisition company (SPAC) focused on medical technology. Last August, Memic announced its merger with MedTech Acquisition Corporation to take the surgical robot public. As of this week, however, the deal is off. Memic is a developer of…

Orphazyme A/S's (NASDAQ:ORPH) board of directors has called for a court-mediated restructuring, prompting the second round of layoffs in less than a year. The in-court restructuring will determine whether any operations can continue if the Company can raise any capital or if it is prudent to sell all or some parts of…

By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT