The U.S. Food and Drug Administration approved Intra-Cellular Therapies Inc.’s Caplyta for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

The U.S. Centers for Disease Control and Prevention said on November 29 everyone aged 18 years and older should get a booster shot, as the CDC looks to tackle a new and highly infectious strain of the coronavirus that is quickly spreading across the globe.

The European Union’s drug regulator on November 19 advised that an experimental Covid-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.

The U.S. Food and Drug Administration said on November 16 it would review Pfizer Inc.’s request to authorize booster doses of the company’s Covid-19 vaccine in all adults “as expeditiously as possible,” with the New York Times reporting that the regulatory nod could come as soon as November 18.

Pfizer Inc. and BioNTech SE on November 9 requested the U.S. Food and Drug Administration to authorize booster doses of their Covid-19 vaccine in all adults, presenting recent data showing the shot would help prevent disease across ages.

New real-world data from the ongoing BICSTaR study demonstrated the continuing benefits of treatment with Gilead’s HIV drug Biktarvy and quality-of-life issues faced by patients who have been treated with the medicine for one year.

Russia will test a nasal spray form of the Sputnik V vaccine against Covid-19 among adult volunteers, according to a state document published on Oct. 12, as the country struggles to rein in rising numbers of infections and deaths.


The U.S. Food and Drug Administration Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously to recommend use of Takeda Pharmaceutical Company Limited’s maribavir (TAK-620) for the treatment of refractory cytomegalovirus (CMV) infection and disease withgenotypic resistance to ganciclovir, valganciclovir, foscarnet or cidofovir in transplant recipients.

Johnson & Johnson submitted data to the U.S. Food and Drug Administration for emergency use authorization of a booster shot of the company’s Covid-19 vaccine in people aged 18 and older.

Janssen Pharmaceutical’s experimental vaccine for a respiratory syncytial virus (RSV) demonstrated an 80 percent efficacy level in adults over the age of 65 years.